What is the compliance perspective of Medical Devices testing

The role of medical devices in screening, diagnostics, and treatment has become critical. Modern medical devices have sophisticated components with digital interfaces. These help to derive meaningful inferences from the data emanating from patients’ vital stats. Since speed and quality lie at the core of the functioning of medical devices, they need to comply with quality standards and regulations. Also, since the functioning of medical devices is regulated by the built-in software, the same should adhere to basic safety guidelines or protocols.

Further, the rate of failure of medical devices has been found to be increasing by the day leading to the establishment of IEC 62304.

What is IEC 62304?

It is the international regulatory standard defining the SDLC requirements of software driving medical devices. The standard was established as it was felt that product testing alone will not ensure the safety of patients, especially when there is a software present. The standard requires every aspect of the SDLC to be scrutinized. These include development, configuration, risk management, maintenance, security, and problem resolution.

IEC 62304 offers a standard framework for the manufacturers of medical devices to design software. By conforming to this standard, manufacturers can fulfill the requirements of medical devices testing thereby generating trust. Also, since the standard is harmonized with the medical device directive practiced in the European Union, it has been acknowledged as a benchmark. The devices adhering to IEC 62304 include

•     Diagnosing, monitoring, or treating patients under medical supervision
•     Contacting the patient - physical or electrical
•     Transferring energy to/from the patient
•     Monitoring or detecting such energy transfer

Digitization in healthcare can have many dimensions. These include monitoring the performance of applications, leveraging the digital ecosystems for the stakeholders, and calculating the quantum of investments to drive digital transformation. The healthcare sector is being transformed with the infusion of new technologies (wearables included) and treatment/diagnostics methodologies. Since devices incorporating new technologies need to deliver results with precision, they should undergo rigorous medical devices testing. Let us discuss the reasons for validating medical devices through comprehensive Quality Assurance.

• Security: Medical devices contain sensitive data about patients’ health, which if breached, can lead to severe consequences. It is only through rigorous healthcare software testing that devices can be made hack-proof. The measures may include identifying vulnerabilities, validating and authenticating user log-ins, performing penetrating testing against firewalls, or encrypting data. Also, medical devices need to adhere to stringent quality standards such as the Health Insurance Portability and Accountability Act (HIPAA). This ensures the protection of patients’ health-related data and information.
• Usability: This is a crucial testing requirement as devices are handled by healthcare professionals while discharging their duties. Since many professionals may find it difficult to handle the features and functionalities of devices, the same should be made simpler. This is where usability testing using automation can help to simplify and enhance the user experience.
• Big data: The healthcare sector deals with a humongous quantum of data based on which inferences are drawn about the health condition of patients. These inferences are further leveraged to plan the right treatment strategy or develop a product. Big data analytics can help to derive the right inferences from the data quickly and accurately. It can help professionals to make informed decisions related to research and development, drug inventions, or curing ailments.
• Device interoperability: Medical devices need to connect and interoperate to deliver the required outcome and user experience. Since the healthcare sector needs to ensure data privacy, security, and regulatory compliance, the role of medical devices testing specialists becomes crucial. So, healthcare testing services need to apply technical expertise, resources, and time to ensure quality, compliance, and business profitability.

The testing of medical devices impinges on meeting the regulatory requirement. Moreover, navigating the regulatory ecosystem is crucial for the successful launch of medical devices or products. It ensures the adherence of devices to attributes like performance, safety, and security. Also, with the increased complexity of treatment protocols, the standards of quality and safety of medical devices should be enhanced. These include adherence to Electromagnetic Compatibility (EMC) testing for devices with power supply and electronic components. The quicker these standards are complied with, the faster companies can expect their products to become market-ready.

Conclusion

The healthcare sector deals with patients’ data and information on a daily basis. To ensure the security of these, the medical devices testing experts ought to ensure interoperability and flawless performance of such devices. This is where adherence to regulatory protocols becomes important to deliver better customer experience and market adoption.

This article is already published on dev.to.

How businesses can achieve ultimate success with a QA culture

Competition forces businesses or technicians to come up with things (read innovations) that they would not do otherwise. In the rat race where businesses are delivering products or services at the drop of a hat, not everything is lapped up by the end customers. At the end of the day, it is quality that plays an all-important role in making an enterprise successful. This is due to the fact that customers of the day are choosy, smart, knowledgeable, and won’t settle for anything less.

In fact, they choose products that meet the highest standards of security, usability, functionality, and performance, among other parameters. However, there can be issues galore when it comes to ensuring the quality of a product or service. To begin with, each product should work seamlessly across devices, operating systems, browsers, frameworks, and networks. This is easier said than done as ensuring that would mean subjecting the product to a rigorous quality assurance exercise.

Why software quality assurance?

Today, good customer experience has become a differentiator for the success of a product or service in the market. This can only come about when end-customers evaluate and accept that product or service based on various quality parameters. However, meeting such quality parameters in the SDLC consistently would require the product to be tested across devices, operating environments, and networks.

In the event of such parameters not meeting the desired standards, the consequences can be immense, both for the customers and businesses. The presence of bugs in a finished product can mar the quality of service. For example, it can allow vulnerabilities to creep in and let hackers steal sensitive personal or business information. Today, when software applications carry sensitive financial and personal information, the presence of glitches can render them vulnerable.

Since the traditional waterfall model has proved to be ineffective in measuring up to the quality standards of today’s products, methodologies like Agile and DevOps have come into play. If earlier, QA testing services used to follow development and integration, today these have become concurrent with them. The focus is on executing QA software testing alongside development to save cost and time. To make DevOps successful, businesses need to develop a QA culture where everyone is an equal stakeholder.

How to enable a robust QA culture?

Building a robust culture of quality assurance in the organization is not easy as it requires establishing a seamless coordination between silo-based departments and processes. The best way to go about the same is discussed below.

Engaging everyone in the process: For start-ups and small businesses, meeting the quality standards with their products need greater involvement of all the stakeholders. In fact, everyone involved with software development (and testing) viz., developers, managers, business analysts, and testers should be a part of the QA process. Except for developers, people can evaluate the functionality of a product and give feedback. The same can then be worked upon by developers to fix glitches, thereby offering a positive experience to the users. This shall make the QA process more efficient and help deliver quality products & services.

Follow Agile methodology: The process shall lead to better communication and collaboration between departments. Also, test management can implement better test automation tools to identify and fix bugs quickly and effectively. The use of QA automation tools can eliminate running of repetitive test cases. Thus, the QA team can focus its time in executing exploratory testing.

How a QA culture can help?

An all-encompassing QA culture can help enterprises to achieve success. They can do so in the following ways.

Better customer experience: A glitch-free application is a result of executing quality assurance and testing thoroughly. The final validation of features and functionalities against expected outcomes allows the application to work seamlessly across environments and customers to enjoy the best experience.

Faster time to market: When quality assurance and testing takes place alongside development following the Agile and DevOps methodologies, glitches are identified and remedied fast in the SDLC. As the workflow gets streamlined, the delivery of the product becomes faster.

Better security: The rising incidences of cybercrime have brought into sharp focus the importance of strengthening the security features of software applications. This can only happen when total quality culture pervades across the organization with every stakeholder being aware of upholding the security protocols, regulations, and standards. This can help to reduce security vulnerabilities and prevent applications from being hacked.

Conclusion

The changing market dynamics and the advent of new technologies have brought the aspect of ‘quality’ into sharp focus. It has not remained the preserve of a single department but a shared responsibility of all concerned. If only a total quality culture prevails in an organization, achieving success can only be a matter of time.

How Software Quality Engineering can help in achieving excellence

The rapid penetration of digital technology through devices and applications has transformed the lives of the end customers. Activities that were considered challenging, inconvenient, and time-consuming in the past are done in a jiffy now. Take, for example, the paying of utility bills, carrying out financial transactions, buying groceries, medicines, apparel, or the booking of tickets. However, there is a flip side to convenience, agility, and speed offered by digitization as well. With an increased level of sophistication of software applications driving the digital revolution, there are instances when things can go wrong. For example, a malfunctioning smoke detector at the house or office not picking up the smoke caused by a fire, the bank failing to notify the customer that his or her account has been compromised, or a digital pill miscalculating the level of blood sugar and administering more than the prescribed dosage of a drug.

All these can have severe ramifications for both the customer and the service provider. This brings into sharp focus the key role of quality assurance in ensuring technology to be an enabler and not a disaster. Further, to achieve success in the competitive business environment, enterprises should look beyond the customer experience, which can be a one-off thing. The challenge is to establish trust with the end-user by assuring the quality of products or services on a consistent basis.

However, this is easier said than done, for quality assurance can often miss a thing or two. This is due to the preponderance of devices, operating platforms, browsers, third-party applications, and networks. To ensure the smooth running of a software application, the same needs to be compatible with the above-mentioned elements. Moreover, in the Agile and DevOps led Software Development Life Cycle (SDLC), where there is a requirement for continuous testing, integration, and delivery, QA should give way to software quality engineering.

What is software quality engineering?

As opposed to quality assurance, software quality engineering deals with identifying the causes of failures and implements a system to prevent them from occurring in the first place. It is focused more on analyzing the technical side of glitches such as their deviation and non-compliance, or the signing of quality prior to the delivery of a product. In most organizations, there is an overlap between the disciplines of enterprise quality engineering and quality assurance. It mainly deals with developing an environment where products or services are designed, developed, tested, and delivered according to the requirements of the customers. Independent quality engineering services take the cross-functional approach by combining multiple business disciplines.

So, with the advent of technologies like AI and ML, Blockchain, Internet of Things, Cloud Computing, and Big Data, among others, the vulnerabilities have increased as well. Since the ramifications for application malfunction are immense, the need for a software quality engineer has become crucial. Let us find out how Quality Engineering or QE can help in achieving excellence in quality.

A quality engineering company offering QE services cover the following areas:

• Agile and DevOps testing
• Test data management
• Service virtualization
• Test automation
• Security testing
• Performance testing

How enterprise quality engineering can help driving excellence

The main focus of QE is to build a QA environment that preempts the presence of glitches and achieve the following outcomes.

Reduces or eliminates vulnerabilities: With the development and testing team working in close proximity, QE offers end-to-end transparency to everyone associated with the build process. This approach helps to detect vulnerabilities and inherent risks early in the SDLC and ensures the initiation of prompt remedial action.

Streamlines coordination among departments: The reasons for glitches to remain unidentified is that every department deals with its turf only. Even if glitches are identified by another department or process, the tendency is to overlook the same and pass the buck. However, with independent quality engineering services in command, the old ways of workflows are abandoned in favor of more coordination and cohesion. Since a commonality of interest is established among departments, the usual blame game is averted.

Enhanced productivity with automation: The flip-side of manual testing such as the lack of coverage area and errors in regression testing can be avoided with test automation. The iterative testing processes are executed quickly resulting in better identification of glitches. As the quality of code improves in the build, the overall delivery schedule becomes better and speedy.

Conclusion

With the level of sophistication increasing in the digital ecosystem, traditional Quality Assurance can come a cropper. It is only through the implementation of software quality engineering involving steps such as service virtualization, performance testing, and test data management, among others, that excellence in the quality of applications can be achieved.

Author Bio

Oliver has been associated with Cigniti Technologies Ltd as an Associate Manager - Content Marketing, with over 10 years of industry experience as a Content Writer in Software Testing & Quality Assurance industry.

This article is originally published on medium.com.

Why you need to take Application Security Testing seriously?

The rapid penetration of digital technology through devices and applications has transformed the lives of the end customers. Activities that were considered challenging, inconvenient, and time-consuming in the past are done in a jiffy now. Take, for example, the paying of utility bills, carrying out financial transactions, buying groceries, medicines, apparel, or the booking of tickets. However, there is a flip side to convenience, agility, and speed offered by digitization as well. With an increased level of sophistication of the software applications driving the digital revolution, there are instances when things can go wrong. For example, a malfunctioning smoke detector at the house or office not picking up the smoke caused by a fire, the bank failing to notify the customer that his or her account has been compromised, or a digital pill miscalculating the level of blood sugar and administering more than the prescribed dosage of a drug.

All these can have severe ramifications for both the customer and the service provider. This brings into sharp focus the key role of quality assurance in ensuring technology to be an enabler and not a disaster. Further, to achieve success in the competitive business environment, enterprises should look beyond the customer experience, which can be a one-off thing. The challenge is to establish trust with the end-user by assuring the quality of products or services on a consistent basis.

However, this is easier said than done, for quality assurance can often miss a thing or two. This is due to the preponderance of devices, operating platforms, browsers, third-party applications, and networks. To ensure the smooth running of a software application, the same needs to be compatible with the above-mentioned elements. Moreover, in the Agile and DevOps led Software Development Life Cycle (SDLC), where there is a requirement for continuous testing, integration, and delivery, QA should give way to software quality engineering.

What is software quality engineering?

As opposed to quality assurance, software quality engineering deals with identifying the causes of failures and implements a system to prevent them from occurring in the first place. It is focused more on analyzing the technical side of glitches such as their deviation and non-compliance, or the signing of quality prior to the delivery of a product. In most organizations, there is an overlap between the disciplines of enterprise quality engineering and quality assurance. It mainly deals with developing an environment where products or services are designed, developed, tested, and delivered according to the requirements of the customers. Independent quality engineering services take the cross-functional approach by combining multiple business disciplines.

So, with the advent of technologies like AI and ML, Blockchain, Internet of Things, Cloud Computing, and Big Data, among others, the vulnerabilities have increased as well. Since the ramifications for application malfunction are immense, the need for a software quality engineer has become crucial. Let us find out how Quality Engineering or QE can help in achieving excellence in quality.

A quality engineering company offering QE services cover the following areas:

• Agile and DevOps testing
• Test data management
• Service virtualization
• Test automation
• Security testing
• Performance testing

How enterprise quality engineering can help driving excellence

The main focus of QE is to build a QA environment that preempts the presence of glitches and achieve the following outcomes.

Reduces or eliminates vulnerabilities: With the development and testing team working in close proximity, QE offers end-to-end transparency to everyone associated with the build process. This approach helps to detect vulnerabilities and inherent risks early in the SDLC and ensures the initiation of prompt remedial action.

Streamlines coordination among departments: The reasons for glitches to remain unidentified is that every department deals with its turf only. Even if glitches are identified by another department or process, the tendency is to overlook the same and pass the buck. However, with independent quality engineering services in command, the old ways of workflows are abandoned in favor of more coordination and cohesion. Since a commonality of interest is established among departments, the usual blame game is averted.

Enhanced productivity with automation: The flip-side of manual testing such as the lack of coverage area and errors in regression testing can be avoided with test automation. The iterative testing processes are executed quickly resulting in better identification of glitches. As the quality of code improves in the build, the overall delivery schedule becomes better and speedy.

Conclusion

With the level of sophistication increasing in the digital ecosystem, traditional Quality Assurance can come a cropper. It is only through the implementation of software quality engineering involving steps such as service virtualization, performance testing, and test data management, among others, that excellence in the quality of applications can be achieved.

Author Bio

Oliver has been associated with Cigniti Technologies Ltd as an Associate Manager - Content Marketing, with over 10 years of industry experience as a Content Writer in Software Testing & Quality Assurance industry.

This article is originally published on medium.com.

Why you need to take Application Security Testing seriously?

The digital ecosystem of today is underpinned on applications that influence us in the way we communicate and interact. The applications are repositories of sensitive personal or business information, which if accessed by inimical forces such as hackers/cybercriminals, the consequences can be catastrophic - both for the individuals and businesses. If we go by statistics, then cybercrime has taken a humongous toll on individuals, businesses, organizations, and entities with an annual loss projected at $1.5 trillion globally. As if on cue and given the ramifications, the global spending on cybersecurity has shown an increase as well and is predicted to touch $170.4 billion by 2022.

With the change in technology, the contours and mechanics of cyberattacks are changing as well. Let us understand the changing trends of cyber-attacks.

New targets: The impact of cybercrime is seen mostly in information theft, which can hit a big blow to the bottom lines of businesses. However, apart from data, the cybercriminals also target the core industrial control systems with the purpose of disrupting and destroying organizations.

Change in impact: Stealing data may have become foremost outcome of any cybercrime incident. However, the changing modus-operandi is more about attacking data integrity. This is done to create distrust in the minds of end-users, clients, and business stakeholders.

New techniques: As people, organizations, and entities are waking up to the menace, cybercriminals are changing their attacking methods. In many cases, they are targeting the weakest link - the human layer - to wreak havoc using phishing and turncoat insiders.

Businesses often do not take the job of application security testing seriously, thanks to the prevalence of several myths:

Myth 1: Our digital assets are protected by firewalls, so we are safe.

Fact: Firewalls can prevent the access of cybercriminals at the network level, that to a certain extent. However, cyber-attacks can take the route of the application layer, which firewalls are not adept at protecting.

Myth 2: The applications are not exposed to the internet and have internal storage and usage.

Fact: In most cases, businesses prioritize protecting their systems and databases from external attacks. However, compromised insiders with authorized system access and familiarity with the system architecture and security protocols can be more dangerous.

Myth 3: Secure Sockets Layer (SSL) technology is foolproof and protects a website from cyber-attacks.

Fact: Even though SSL is key to strengthening the cybersecurity architecture of a website, it can be exploited by cybercriminals. The latter can make use of low encryption algorithms to decrypt traffic and steal information.

Steps to enhance application security testing

When so much is at stake for individuals and businesses, investing in an application security testing methodology has become critical. Let us discuss the steps that enterprises can take to enforce software application security testing.

Complying with security protocols: With cybersecurity becoming critical in ensuring the smooth functioning of the digital ecosystem, the industry has set up some regulations and standards. These include ISO 27001, NIST, HIPAA, PCI DSS, and Sarbanes-Oxley, among others. Enterprises must comply with the above-mentioned standards to avoid penalties, censure, and filing of lawsuits for damages.

Conduct penetration testing: It calls for an in-depth security assessment of the system’s architecture to identify its vulnerabilities. The vulnerabilities can get into the system due to poor coding, weak design elements, improper configuration management, and poor implementation of security policies and standards.

Implement DevSecOps: The DevOps methodology can help enterprises in accelerating the time to market, enhance the quality of products or services, improve the customer experience, and achieve ROI. It calls for the continuous integration and testing of codes and breaking silos between the development and operations teams. However, given the emerging dimension of cybersecurity, security should be made an integral part of DevOps where everyone in the pipeline should be made accountable.

Identification of outliers: Any software application security testing should be able to identify the outliers. In other words, any malicious behavior of the code should be quickly identified and set for remedial action.

Supervision of the IoT network: The advent of IoT technology is making communication between devices a reality. However, this is also giving rise to the issues of security breaches. This calls for continuous monitoring of the IoT network to check any cybersecurity breaches.

Conclusion

Securing the IT system has become the need of the hour given the wider ramifications of cybercrime. In the digital ecosystem where applications help to connect devices and systems, a single vulnerability can compromise the entire infrastructure. By rigorously implementing web application security testing, vulnerabilities can be identified, and an overarching protection can be ensured.

Author Bio

Oliver has been associated with Cigniti Technologies Ltd as an Associate Manager - Content Marketing, with over 10 years of industry experience as a Content Writer in Software Testing & Quality Assurance industry.

This article is originally published on dev.to.

How has Automation influenced the Testing Landscape

Today, software development has become a complex process due to the need for compatibility of software across devices, operating environments, browsers, and networks. Add security compliance to the list and the task becomes even more challenging. To ensure the software runs seamlessly across digital environments as mentioned above, it should undergo a rigorous testing exercise. This is important to achieve customer satisfaction – the key determinant to stay competitive. So, how do you choose a testing methodology that delivers excellence in all the areas of software including, performance, security, functionality, and usability, among others? The answer can be found in following a mix of manual and test automation practices with the latter forming the mainstay.

Why test automation?

The traditional form of testing software aka manual testing does not quite match up to the evolving requirements of testing. Since the software applications of today combine cutting-edge technologies like AI & ML, IoT, Big Data, Cloud Computing, and others, the testing requirements have grown manifold. These require checking the performance of the software on multiple channels involving scores of users. This is where manual testing can be time-consuming, error-prone, and tedious thereby putting considerable strain on the human resources. The automation testing approach, on the other hand, can address the shortcomings of manual testing and relieve the human resources to focus on other areas.

With enterprises aiming to deliver software faster to the market, they often take risks with its quality. This involves downplaying or bypassing the testing requirements. Moreover, testers too suffer from fatigue when executing repetitive tests involving huge data. This often leads to situations where enterprises are unable to manage the expenses incurred in service delays and performance issues. Let us find out how automated software testing has changed the testing landscape for the better.

Key benefits of software test automation

QA involves executing a series of tests involving data and comparing the expected outcomes against the actual ones. Here, test automation can guarantee software quality without much human intervention. The best thing about executing automated testing services is its increased frequency of implementation with minimal effort. And if such implementation leads to better results, then achieving customer satisfaction can only be a matter of time.

High test coverage: Since any software with an omnichannel interface encompasses plenty of features and functionalities, it ought to be tested for the latter. A QA automation testing process helps to validate the quality of all features and functionalities thereby increasing the scope of testing. An automated suite can conduct repeat testing with plenty of variables and data thereby enhancing the quality of the software application. It is important to note that manual testing is fairly limited in its scope vis-a-vis testing the features of an application.

Meeting DevOps goals: DevOps has emerged as the latest methodology to develop and deliver superior quality software. It focuses on shift-left testing where testing is conducted alongside development in sprints. Since DevOps is all about achieving continuous integration and testing throughout the SDLC, the role of software test automation assumes salience. It ensures each code is tested thoroughly during the development process before being integrated into a suite. Also, any updation of software based on market demand and/or customer feedback is put through regression testing using automated tools.

Quick detection of glitches: As the SDLC follows the shift-left process, codes are validated using an automated test suite. During the process, glitches get identified at the development stage and fixed. This ensures faster delivery of quality software and saves a considerable amount in time and cost. The latter would have been incurred if the glitches were identified later, either during testing at a later stage or through customer feedback.

How the testing landscape changed with automation

The testing landscape encompasses a number of testing viz., unit testing, functional testing, integration testing, load testing, and regression testing, among others. Automation has helped the above-mentioned areas of testing to be accelerated. Let us find out how.

Unit testing: This type of testing ensures how each piece of code shall behave once it forms a part of the overall software suite. It is usually created by developers and provides feedback on the specific performance of the code. It tells developers whether the code is performing the tasks as expected and can arguably provide the best ROI for automation.

Integration testing: It involves the testing of multiple components of a software suite. Here, even though the components may exist independently, they are interconnected in the larger software suite. By following a test automation strategy, the integration of various components of software such as email services, analytics, third-party components, databases, deployment infrastructure, etc., are tested to ensure the seamless performance of the software.

Load testing: Any software should undergo proper load testing to ensure its components can handle peak load situations. By measuring both normal and peak load thresholds, the software can be scaled up when the crunch time comes. Here, automated load testing tools can come in handy to perform load testing on demand and involves simulating traffic at high speed. This helps to identify the non-functional issues and ensure the scalability and performance of the software.

Functional testing: It checks if the software is doing what it is expected to do instead of how it does. Here, the functionality of the interface or sundry end-to-end components is verified without getting into the nitty-gritty of coding that drives it. By automation, functional testing can be conducted umpteen number of times without any human intervention. However, the test suites should be maintained properly to prevent any false positives.

Regression testing: It checks the functioning of the original features of software when a new one is added. Conducting it manually in-house can be tedious and ideally requires engaging automated testing services. Automated testing can carry out comprehensive regression testing involving unit testing, integration testing, and functional testing. However, conducting UI level testing may not yield the desired results as the UI can be volatile and cause test failures.

Mobile testing: This type of testing can be challenging, for it involves compatibility, functional, performance, security, and UI/UX testing. Mostly the testing is done on real or simulated devices by automating some of the tasks. However, the results can often be sketchy given that they are executed on emulators. Also, the results of such testing would depend on the reliability of the device platform.

Conclusion

Test automation has brought about a significant improvement in the testing landscape. It has been able to address some of the lacunae of manual testing thereby enhancing the quality of software. Enterprises should incorporate automation in their SDLC to ensure the software ticks all the checkboxes for quality. However, as mentioned at the beginning, automation in testing is not the be-all and end-all of everything and should be executed in consonance with manual testing.

Author Bio

Oliver has been associated with Cigniti Technologies Ltd as an Associate Manager - Content Marketing, with over 10 years of industry experience as a Content Writer in Software Testing & Quality Assurance industry. Cigniti is a Global Leader in Independent Quality Engineering & Software Testing Services with CMMI-SVC v1.3, Maturity Level 5.

This article is originally published on dev.to.

How to approach Medical Device Testing

The critical role of medical devices can be understood from the fact that any component or software failure can put the lives of patients in jeopardy. To ensure these devices function to their optimum level on a consistent basis, they are subjected to a plethora of regulations and compliances such as IEC 60601-xx, IEC 17025, ISO 14708-3, and ISO 14971. In fact, the World Health Organization (WHO) has recommended to all governments the need to set-up regulations for medical devices. This is to assure all stakeholders of the ability of devices in offering necessary risk mitigation and minimizing harm in case of any malfunction. As a result, manufacturers have undertaken medical device testing to check various components and embedded software within such devices for enabling consistent performance.

The above requisites called for the medical devices testing specialists to define and implement the right testing strategy throughout the manufacturing process. To cite an example, manufacturers should validate every functionality of the medical device right from the concept and design phase for better test coverage. On the other hand, should they test the manufactured devices for functionalities and identify glitches therein, the cost of implementing solutions will be high and time-consuming.

Medical device testing identifies the risks and impact of various environmental conditions and focuses on the reliability of devices vis-a-vis the inputs. It involves various types of testing related to the lifecycle, compliance, interoperability, reliability, and performance of medical devices. Medical device functional testing also focuses on risks concerning electrical, mechanical, and environmental aspects. The medical devices testing experts conduct technical testing on the subassemblies, components, and the finished product to ensure the latter’s effectiveness.

Devising an impactful strategy for medical device testing

The medical devices testing specialists should take inputs from the design team to create test structures that conform to the software, hardware, and other requirements. Moreover, the test requirements for devices are based on the manufacturing process, component specifications, and other functional specifications. These help manufacturers in carrying out tests throughout the manufacturing process - from selecting individual components to their final assemblage.

Practical approach to medical device testing

Any practical strategy to test medical devices should involve phases like analysis, design, deployment, closure, and maintenance. To validate testing as per the test requirements and parameters, the following types of testing are undertaken.

Microprocessor testing: To conduct effective performance testing of medical devices, they should be subjected to solid electronic testing. Since most medical devices come with built-in microprocessors, the test process should commence with microprocessor testing. Importantly, medical devices testing experts should execute such testing prior to the integration of microprocessors to the Printed Circuit Boards (PCBs). Testing the transistors and integrated circuits inside a microprocessor should consider their interconnection and logic gate functions.

Post integrating the components to the PCB, the QA team uses common defects of an assembly model and identifies the wrong component, open interconnect, and missing component. Moreover, any modern test equipment allows direct measurement of device components in small units. However, care must be taken to ensure these components within the PCB should not impact the functioning of the whole medical device. Even though functional testing is a crucial part of the testing process, it does not suffice to find other manufacturing defects. This necessitates additional troubleshooting.

Test automation: This process is conducted by using an electronic system comprising instruments, a computer, and software. While testing high-tech medical devices with varying current and voltage requirements, the test team might grapple with generating test cases and measuring their accuracy.

Interoperability: Testing medical devices should invariably check for the interoperability of devices and applications to uphold data privacy and security. The tests should be recorded for the purpose of audit and compliance. With innovations involving the Internet of Things, there is a need for the applications, devices, and controls to integrate with the software at the core.

Security: In today’s challenging digital scenario there is an urgent need to make the embedded software within medical devices hack-proof. These include adopting measures like firewall testing, encrypting the user data, and the authentication and validation of user log-ins, among others. The security testing of devices should aim at protecting the health information of patients and ensure they adhere to the provisions of the Health Insurance Portability and Accountability Act.

In addition to the above types of testing, medical devices should be tested for regulations and compliance, especially as per FDA. Finally, the practical approach to testing medical devices should include GUI testing, performance testing, non-GUI testing, compliance testing, interoperability testing, behavior testing, reliability testing, and user acceptance testing.

Conclusion

A robust approach to testing medical devices is critical to ensure their effectiveness. It can help manufacturers from preempting situations like device recall and save money in retesting devices should glitches be found. In an industry that requires stringent adherence to quality, manufacturers should engage organizations with domain knowledge and experience.

Author Bio

Oliver has been associated with Cigniti Technologies Ltd as an Associate Manager - Content Marketing, with over 10 years of industry experience as a Content Writer in Software Testing & Quality Assurance industry. Cigniti is a Global Leader in Independent Quality Engineering & Software Testing Services with CMMI-SVC v1.3, Maturity Level 5.

This article is originally published on medium.com