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Validation

How to Manage Medical Device Verification and Validation Risks

Verification and validation ensure that medical devices meet appropriate standards and will provide intended benefits. Both steps are essential in meeting regulatory requirements, so it’s important to consider verification and validation early in the design stage when developing requirement specifications for the product.

“Inadequate process validation is one of the most common issues leading to warnings from the U.S. Food and Drug Administration (FDA),” notes Regulatory Focus, a publication of the Regulatory Affairs Professionals Society, which reported that the problem may be difficult to address if regulatory and quality professionals don’t understand what validation consists of.

It’s important to recognize the ways in which validation can be defined, as well as how it differs from verification. Under Code of Federal Regulations 21CFR820, the FDA has separate definitions for process and design validation. Design validation ensures that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions. Process validation gives evidence that a process consistently produces a result where specified requirements continue to be met.

While validation is concerned with the end product, verification ensures each element of a device meets specifications and standards. For this reason, verification should always be the primary consideration. Regulatory Focus provides a helpful cooking metaphor to remember: verification involves the meal’s ingredients and the recipe, and validation involves how the meal tastes.

Managing Validation Tools is Essential

Medical device validation is a complex process that requires specific expertise across a broad range of technical issues. If a company doesn’t employ at least one qualified validation professional on staff, it should consider outsourcing the role.

“Process validation is a key element of identifying and mitigating risks for medical devices,” which is a significant focus of the FDA and other global regulators, said Regulatory Focus. Additionally, today’s connected medical devices require software validation in addition to traditional forms of device validation to help identify and mitigate risk and reduce vulnerability to cyberattacks for these products.

Even the tools used to validate medical devices require their own validation. According to Intland Software, tool qualification in medtech development is the process of evaluating, documenting, and demonstrating whether a tool used to create a medical device is up to standards. They note that best practices in medtech tool validation include:

  • Use industry guidelines – Industry guidelines with accepted standards will make the validation process easier and clearer.
  • Involve stakeholders from the outset – Identify team members and set expectations for the project up front, to ensure that input and approvals can be quickly and easily obtained as the project progresses.
  • Use vendors as a resource – Ask service providers to review validation documentation before it’s executed and to provide expert guidance on their tools.
  • Document everything – This serves as evidence that shows the intended use of the tool and that it’s been tested to ensure functionality, which provides proof if needed by customers or auditors later.
  • Future-proof your setup – Once validated, a tool must maintain its validated status. Place all tools under change control processes so when they’re upgraded, they can retain validated status.

What happens at the medical device verification and validation stages can have an impact on cost, final design, and overall manufacturability. To manage these risks in an effective manner, company leadership and product designers must proactively invest the time and resources that are required.

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