Comprehensive Guide to Medical Device Testing: Ensuring Safety and Compliance
Explore medical device testing types, processes, regulatory requirements, and challenges to ensure safety, performance, and compliance with global standards.
Medical device testing is a necessary process that must be performed by all the manufacturers worldwide so as to ensure the effectiveness, safety and performance of their device. Medical device testing involves multiple steps that cover stages from ideation to the product launch.
Medical device manufacturing and design companies must know about the different types of testing to understand which one is the best for their device and how it should be performed.
In this blog, we have provided a comprehensive overview of medical device testing, its types, the primary steps involved in medical device testing, regulatory requirements, challenges, and solutions to ensure a streamlined path to assessment and compliance.
What is Medical Device Testing?
Medical device testing verifies the safety, effectiveness and performance of a medical device. This comprises a series of experiments, evaluations, and tests to ensure that a medical device is performing as per the standards, its intended use, and complies with the regulatory requirements. Medical device testing aims to assess a medical device’s biocompatibility, design, durability, electrical safety, functionality, sterility, and usability based on the purpose and scope of every test.
What are the Different Medical Device Testing Types?
There are a variety of medical device testing that exist and each has a unique purpose of showcasing that the device is overall safe and effective. Here we have outlined the most common medical device testing types along with details about each test type.
1. Biocompatibility Testing
Biocompatibility testing evaluates a medical device’s compatibility and safety with the human body. This testing is performed for medical devices that come in direct or indirect contact of the human body. Biocompatibility testing consists of several sub-tests, the applicability of which depends on the level and duration of contact of the medical device with the human body. In biocompatibility testing for medical devices, you examine the device’s interactions with biological systems and evaluate if it delivers biologically safe performance and results. This is an essential requirement to ensure biological safety of a medical device.
2. Environmental Testing
Environmental testing refers to verifying a medical device’s capability and reliability to withstand different environmental conditions like humidity, pressure, shock, temperature, and vibration.
3. Functional Testing
Functional testing refers to examining the functional aspects such as features, interactions, and interfaces of a medical device. This testing is done during the development lifecycle of a medical device to ensure that the device is accurate and its functions work as intended.
4. Integration Testing
Medical device integration testing involves verifying the interactions and interoperability between a medical device and other components or systems it communicates with. This testing ensures all device parts work together as intended without causing unintended behavior or compromising safety.
5. Material Testing
Material testing refers to the chemical analysis of materials to identify components that may affect biocompatibility, performance, and safety standards. This information is used to reduce toxicological testing in new designs, design changes, and production. This test assesses the materials’ biological interactions, chemical composition, and mechanical properties.
6. Performance Testing
Performance testing refers to assessing a medical device’s effectiveness, functionality, and reliability under simulated conditions. The device is ready for clinical use once it meets the required standards and all the issues, performance bottlenecks and limitations associated with the medical device are resolved. This type of test is a significant part of the design validation process.
7. Safety Testing
Safety testing refers to assessing the associated risks of using medical devices. These risks include electrical, electromagnetic compatibility (EMC), mechanical, and thermal safety. Data gathered from this test is used to fix risks and ensure that the device is safe and reliable to use.
8. Security Testing
Security testing refers to detecting and resolving loopholes that can affect the reliability of critical information in a medical device with software components. This test ensures that the medical software solution is protected and secure from data breaches, unauthorized access, and other cyber-criminal activities. To learn more about cybersecurity requirements and testing, refer to our article on cybersecurity standards and requirements for medical devices.
9. Software Validation and Verification
Software validation and verification examines medical devices with software components to ensure accurate performance, reliable performance, and requirement compliance.
10. Usability Testing
Usability testing refers to observing user interactions and gathering feedback in a simulated environment like a medical device testing laboratory to evaluate a medical device’s utility. This test aims to ensure that a medical device is effective, safe, and user-friendly.
Medical Device Testing Process
Given that medical device is a critical step in medical device design and development, methodical steps must be followed The process of medical device testing includes 5 MAJOR steps:
1. Planning and requirement analysis
In the first step of medical device testing, one must identify market, regulatory, and user requirements. Then, conduct an ISO 14971-based preliminary risk assessment. Lastly, develop an exhaustive test plan outlining objectives, methodologies, resources, and timelines.
2. Design verification and validation
Design verification and validation is the second step of a medical device testing process. As a part of design verification, one must evaluate individual functionality components and perform unit, integration, and system testing. For design validation, the medical device must be tested such that it should mimic real-world use and should collect clinical data in order to verify the performance and safety of the device.
3. Preclinical testing
The third step of medical device testing includes preclinical testing. For preclinical testing, one must assess the compatibility of materials with biological tissues. This testing step or testing may not be required by every medical device company and is typically required for medical devices that are in extensive contact with the human body to achieve their intended use.
4. Regulatory and other testing
The fourth part of the medical device testing process includes regulatory testing. In regulatory testing, ensure compliance with standards like IEC 60601, and relevant FDA or EU MDR requirements. One must also ensure that the labels and packaging meet regulatory and user requirements.
5. Clinical trials
The fifth medical device testing step is clinical trials. In this step, you must conduct initial small-scale trials to identify potential issues. You must also perform large-scale trials to gather comprehensive data on effectiveness and safety. However, not all medical devices need clinical trials.
Regulatory Requirements for Medical Device Testing
The importance of testing cannot be undervalued. It is critical for medical device companies to ensure they are aware of all the testing they need to do and how these tests should be done early on. For that reason, it is good to understand the various regulatory requirements that call for testing. Countries worldwide have their own set of regulatory requirements that medical device manufacturing companies targeting those countries must adhere to. Some of the most prominent ones are as follows:
1. FDA Regulations for medical device testing
The FDA is responsible for reviewing the medical devices in the US. The FDA requires a thorough risk-based classification with a medical device testing process for each risk category.
⦿ Class I devices (ones with the lowest risks) must adhere to general controls, including good manufacturing practices (GMP), labeling, and premarket notification (if not exempt). Given the limited risks of these products, the extent of testing requirements are on the lower side.
⦿ Class II devices (ones with moderate risks) require adherence to special controls like performance standards, post-market surveillance, and specific labeling. Based on a medical device’s intended use, FDA has prescribed the tests that need to be done for different devices, most of these testing are for demonstration of safety and performance.
⦿ Class III devices (ones with the highest risks) must follow stringent medical device testing processes. Medical device testing for Class III devices include clinical trials.
Furthermore, the FDA requires that all manufacturers adhere to its Quality System Regulation (QSR) when designing medical device testing protocols, and executing testing to ensure device quality throughout the product life cycle. All these medical device testing requirements put forth by the FDA ensure that effective and safe medical devices reach the US market.
2. EU MDR requirements for medical device testing
The EU MDR 2017/745 governs the manufacturing, marketing, and use of effective and safe medical devices in the European Union countries. Replacing the previous Medical Device Directive (MDD), it introduced stricter requirements to ensure the safety and performance of medical devices.
The regulation categorizes devices into four classes – Class I, IIa, IIb, and III, based on their risk levels. Devices with higher risk levels must undergo rigorous scrutiny and testing including clinical trials.
It mandates comprehensive risk management, stringent clinical evaluation requirements, and post-market surveillance. As per the EUMDR and the EUIVDR, testing to be conducted depends on the risk category and the device’s indications for use, features and technological characteristics.
Recognized standards for Medical Device Testing
There are several commonly used standards for medical device testing that medical device manufacturers must be aware of. The following outlines what are some of these common standards, what’s the purpose of each of the standards, to which medical devices these standards apply, and how they help.
IEC 60601-1 (Medical Electrical Equipment – General Safety) & Collateral/Particular Standards
Purpose: This standard helps in showcasing the electrical safety of medical devices.
Applicable to: Electromechanical medical devices like the patient monitors, infusion pumps, and ventilators.
How It Helps: When a medical device passes testing designed according to this standard it confirms that the medical device will not cause any electrical, mechanical or thermal hazard to the patient and operator.
IEC 62304:2006 (Software Life Cycle Processes)
Purpose: This standard provides a framework for the development and maintenance of a medical device software.
Applicable to: Medical devices with embedded or standalone software such as imaging software, insulin pump software, and robotic surgical system software.
How It Helps: Ensures the safety and effectiveness of software through rigorous development, validation, and maintenance processes.
ISO 10993 Series (Biocompatibility Testing)
Purpose: Evaluates the biological risks of medical devices which come in contact with the human body directly or indirectly.
Applicable to: Implantable devices, surgical instruments, wound dressings, etc.
How It Helps: Demonstrates that the materials used in a medical device are non-toxic, non-irritant, and biocompatible, thereby preventing a possibility of adverse reactions in users or patients using the medical device.
ISO 11607-1 & ISO 11607-2 (Packaging for Sterile Medical Devices)
Purpose: This standard determines requirements for packaging sterile medical devices.
Applicable to: Sterile surgical instruments, implants, syringes, diagnostic kits.
How It Helps: When a medical device passes testing designed as per this standard, it showcases that the packaging of the medical device is robust and shall prevent contamination and maintain sterility of the medical device until its use.
ASTM F1980 (Accelerated Aging for Sterile Barrier Systems)
Purpose: This standard provides guidelines to simulate real-time aging and shelf life of sterile medical device packaging.
Applicable to: Packaged sterile devices like catheters, syringes, and implants.
How It Helps: When a medical device passes testing as per this standard it is established that the device’s packaging and sterility shall be maintained over its expected shelf life.
ASTM F88 (Seal Strength Testing of Medical Device Packages)
Purpose: This standard ensures sterility by measuring the strength of package seals.
Applicable to: All packaged medical devices that need seal strength and intact packaging for their integrity and usage.
How It Helps: Testing of a medical device as per this standard helps in verifying packaging and the associated seal integrity, preventing contamination and ensuring usability of the medical device.
USP <71> (Sterility Testing of Medical Devices & Pharmaceuticals)
Purpose: This standard establishes sterility test methods to confirm the absence of viable microorganisms.
Applicable to: Sterile devices, pharmaceutical containers, and injectables.
How It Helps: Testing per this standard ensures compliance with sterility requirements before market approval via the FDA or any other regulatory body of the target country.
USP <87> & USP <88> (Biological Reactivity Testing for Medical Devices)
Purpose: This standard evaluates in vitro and in vivo biological reactivity of medical device materials.
Applicable Devices: Implantable and blood-contacting devices.
How It Helps: The standard confirms that the materials used in the device are safe for human contact.
ISO 18562 (Biocompatibility of Breathing Gas Pathways in Healthcare Applications)
Purpose: This standard helps in evaluating the safety of materials in respiratory medical devices.
Applicable to: Ventilators, anesthesia machines, CPAP devices.
How It Helps: Testing performed in accordance with this standard confirms that the material when used in medical devices with respiratory clinical application, does not release harmful substances.
IEC 60601-1-2 (Electromagnetic Compatibility – EMC)
Purpose: This standard defines the requirements for medical devices’ resistance to electromagnetic interference.
Applicable to: All electronic medical devices, especially those used in hospitals.
How It Helps: Once testing for a medical device is performed as per this standard, it helps in showcasing that the medical device shall not malfunction due to electromagnetic interference from other equipment.
ISO 14155:2020 (Clinical Investigations of Medical Devices for Human Subjects – Good Clinical Practice)
Purpose: This standard establishes guidelines for conducting clinical trials for medical devices.
Applicable to: Investigational devices undergoing clinical studies.
How It Helps: Adherence to this standard ensures that ethical, scientifically sound, and regulatory-compliant clinical investigations are performed for medical devices.
Now that we have learnt the various standards that are generally utilized for medical device testing, it’s time to learn the most common challenges companies face while conducting testing.
Challenges in Medical Device Testing
⦿ Knowing what tests to perform:
It’s not straightforward for companies to be able to understand what tests are required for their devices. There certainly is no standard list for medical device testing. However, it depends widely on the medical device’s intended use, performance, and many other factors. Given the ambiguity, it can be daunting to finalise the required testing without expert help.
⦿ Choosing the right standards:
Even when the right tests are identified, choosing the right standard remains another challenging task, especially with the large number of test standards that are currently available for medical devices.
⦿ Third-party testing:
Medical device manufacturers must rely on third party testing for comprehensive testing and reports, however, choosing the right third parties or test labs can be challenging. If an apt lab isn’t selected the time and money spent on testing can all be wasted. Medical device companies should take expert help to select a trustworthy lab that can do a good job with the testing and yet be cost effective.
⦿ Improperly designed tests:
Often medical device companies do the right testing with the right labs using the right standards, however, if care isn’t taken during protocol creation, execution of testing, recording of data, and report creation all other efforts can go in vain. Good documentation practices and an expert review can certainly help address this challenge.
⦿ Unexpected failures:
When conducting medical device testing, every test should have a well defined acceptance criteria and to set oneself up for success, design of experiments should be utilised. Such a proactive approach reduces the unexpected failures during medical device testing. Efforts should be put in not just at the time of testing, but also during design, so you know what tests your device is expected to pass and you design for success.
⦿ Privacy and regulatory concerns:
You may face challenges obtaining live patient data due to privacy and regulatory concerns. This barrier makes real-world testing difficult and requires extra measures to protect patient information. Additionally, adhering to regulations like GDPR and HIPAA add complexity and constraints to security testing.
Conclusion
In conclusion, medical device testing is crucial for ensuring the effectiveness, performance, and safety of devices. Despite its importance, companies often tackle this all by themselves and face significant challenges which results in a loss of time and resources. Ineffective testing can cause problems throughout the medical device lifecycle. At the pre-market stage it can result in delays in getting a regulatory approval or a rejection to your application. While at the post-market stage it can lead to device failures, safety issues, recalls, regulatory non-compliance, and risks to patient health. Working with a knowledgeable global regulatory consultant can make the testing process more efficient, help meet international standards, tackle challenges effectively, and create a clearer path to market approval and successful launch and sustenance of the medical device. Take the first step today! No matter where you are in your medical device design, testing is something you have to think about, so you can set yourself up for success!
