Verification vs. Validation of Medical Devices

verification vs validation

Design verification and design validation are important quality assurance activities during medical device design that help ensure a medical device is high quality and fits its intended purpose. The results of the validation and verification activities confirm that the product is safe, effective, and fit for its intended use. Often, they are performed in combination, with verification occurring during the development process and validation happening at the end of the development process before releasing the product for sale. In this article, we review the similarities and differences between the two processes.

What are verification and validation?

Verification is a process that checks that a product, service, or system meets specified requirements. It typically involves reviewing design documents, conducting inspections, and performing bench testing to determine whether the product design is correct. In short, verification is the process of reviewing documentation and testing the design to prove it adheres to all specifications so far.

Validation is a process for evaluating a system or component during or at the end of the development process to determine whether it satisfies the specified requirements. It is used to confirm that a product is functional, meets the requirements, and is fit for its intended purpose.

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What happens during verification?

During verification, the development team compares the product to the product development specification (PDS) to ensure that it meets them. This may involve reviewing design documents to ensure that the product design follows relevant standards and regulations, conducting inspections of the product to verify correct manufacturing and assembly steps, and performing bench testing to confirm that the product meets the specified requirements. Verification activities are used throughout the design and production process and can involve design reviews, FMEA, bench testing, and code review. The results of the verification testing process confirm that the product is ready to proceed to the next stage of the development process.

What happens during validation?

During validation, manufacturers test a system or component checking that it functions correctly and meets the specified product requirements. Validation activities include evaluating the product in real-world or operating environments to ensure it performs as expected under normal conditions. There are a few different types of testing that you can perform, such as functional testing, performance testing, stress testing, load testing, usability testing, interoperability testing, and compatibility testing. Validation typically occurs at the end of the development process. The validation testing results confirm that the product or device is ready for launch.

What are the differences between verification and validation?

While verification and validation are related, they are different activities with different goals and are typically performed at separate times during the development process. There are five main differences between verification and validation these are:

  • Purpose: Verification proves the manufacturing process produces the correct product. Validation proves that the product works as intended.
  • Timing: Verification is typically performed during development, while validation happens after product development.
  • Methods: Verification occurs through reviews, inspections, and bench testing that do not involve real-world testing. Validation involves using the product and evaluating its performance in a live environment.
  • Output: Verification activities produce outputs such as review and inspection reports. Validation activities produce outputs such as test and acceptance reports.
  • Responsibility: Verification is typically the development team’s responsibility, while validation is the responsibility of an independent testing group.

Let us look at a standard surgical stapler for a real-world example of the differences. At a rudimentary level, the stapler must fit comfortably in a surgeon’s hand and reliably fire staples in succession into tissue. Verification involves test-firing staples into a simulated tissue or foam to show that the stapler functions as designed. Validation tests that the stapler works in an operating room while being used by a surgeon on human tissue.

What are the FDA requirements for design verification and design validation?

The Food and Drug Administration (FDA) has specific guidelines for medical device design validation and verification. These guidelines fall under the design controls portion of current good manufacturing practice (cGMP) outlined within the Code of Federal Regulations (CFR). All medical device manufacturers operating within the United States are legally required to meet these requirements.

Verification, as defined by the FDA, is “confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.” In short, the FDA requires confirmation by objective evidence that design output meets design input. The FDA requires verification for all processes, including processes not critical to the quality of the product. Verification activities include various tests such as mechanical and electrical bench testing and tissue testing.

According to the FDA, design validation involves “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” This means manufacturers must prove that the device specifications conform to the intended use and user needs. The FDA requires validation for processes critical to product quality, such as manufacturing processes, cleaning processes, and processes used to test the product. Some examples of design validation tests include clinical trials, usability testing, and biocompatibility testing.

The FDA requires that organizations document validation and verification and that the documentation is available for review during inspections. The FDA also requires that medical device manufacturers conduct validation and verification activities systematically and scientifically and that the results of these activities be thoroughly documented and reviewed.

In addition to these requirements, the FDA has specific guidance on the validation and verification of computer systems in the medical device industry. This guidance covers software used in manufacturing the product, computer systems used to collect, process, and report data, and computer systems used to control critical production processes.

If your organization performs validation and verification inadequately during medical device development, it can result in defects or failures that may cause injury, illness, or other harm to patients. It can also lead to recalls, lawsuits, and other costly issues for the manufacturer, such as harm to the company’s reputation and customer satisfaction.

In addition, if a medical device does not pass the necessary regulatory review process due to insufficient validation and verification, it may not be approved for sale or use. The result could be significant financial losses for the manufacturer and a delay in getting the device to patients who need it.

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How do you verify a medical device?

Medical device verification guarantees that devices are designed and implemented correctly and meet the necessary standards and regulations set by the FDA. The steps involved in performing verification of a medical device include:

    1. Identify the verification requirements: The first step in performing verification is to identify the device requirements. This process may involve reviewing regulatory requirements, standards, and other relevant documents to determine what needs to be verified.
    2. Develop a verification plan: A verification plan outlines the scope, objectives, and approach for the verification process. The plan should specify the verification methods and criteria used, as well as the resources and personnel needed to perform the verification.
    3. Review design documents: A review of design documents, such as design specifications and drawings, ensure that the device design complies with relevant standards and regulations.
    4. Conduct inspections: Device inspections verify the correct manufacturing and assembly of the medical device.
    5. Perform walkthroughs: Conduct walkthroughs of the design and implementation of the device to identify any issues or potential problems.
    6. Perform static analysis: Perform a static analysis of the device to identify any issues or potential problems. Static analysis is a means of debugging involving testing the device against the requirements.
    7. Evaluate the device against relevant standards and regulations: Evaluate the device’s design and implementation against ISO and FDA regulations, ensuring compliance.
    8. Analyze and document the results: The results of the verification process should be thoroughly analyzed and documented. This involves creating reports or other documentation to summarize the results of the verification activities. You are required to store the results within the DHF following the FDA’s record requirements.

How do you validate a medical device?

In the medical device industry, validation is particularly important to confirm that the device is safe, effective, and fit for its intended use. The steps involved in performing validation of a medical device include:

  1. Identify the validation requirements: The first step in performing validation is to identify what requirements the device needs to meet. This process usually involves reviewing regulatory requirements, standards, and other relevant documents to determine what needs to be validated.
  2. Develop a validation plan: A validation plan outlines the scope, objectives, and approach for the validation process. The plan should specify the validation methods and criteria used, as well as the resources and personnel needed to perform the validation.
  3. Conduct functional testing: Functional testing confirms that the device performs as intended and meets the specified requirements. The device undergoes a series of tests to see if it functions correctly.
  4. Conduct performance testing: Performance testing demonstrates that the device can withstand the intended use and environment
  5. Evaluate the device in a live operational environment: The device is evaluated in a live environment to confirm that it performs as expected under normal conditions. An example is clinical testing.
  6. Analyze and document the results: The results of the validation process should be thoroughly analyzed and documented. You will need to store the reports within the DHF following the FDA’s record requirements.

In conclusion, design verification and design validation activities are an important part of a quality system that demonstrates product or medical device quality and safety. These processes can help identify and assess risks and address them before they cause damage or harm to the end user. This leads to enhanced safety and quality as well as improved customer satisfaction. 

Failing to perform verification and validation can have serious consequences, such as defects or failures that may cause injury, illness, or other harm to patients, as well as recalls, lawsuits, and other costly issues for the manufacturer. It is important for manufacturers to properly plan and conduct these activities to meet regulatory requirements and maintain the quality and safety of their medical devices or products. If you are unsure how to perform verification and validation on your product or medical device or would like some expert advice while navigating the regulatory process, contact us, we would be happy to help.

About Synectic Product Development: Synectic Product Development is an ISO 13485 certified, full-scale product development company. Vertically integrated within the Mack Group, our capabilities allow us to take your design from concept all the way to production. With over 40 years of experience in design, development, and manufacturing, we strive for ingenuity, cost-effectiveness, and aesthetics in our designs.  Learn more about our medical device design services and see how we can help your next project.