Medical Device Process Validation is the Key Part of a Quality Process

[Adam Fleming]

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA standard for medical device process validation is CFR Part 820, Section 820.75(a), according to which, “where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures”.

 

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The need for medical device process validation First of all, why should medical device process be validated? The rationale for this is spelt out by the FDA: “The organization shall validate any processes for production and service condition where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered”.

Further, medical device process validation helps in a number of ways:

• It ensures safety of the device
• Increases customer satisfaction and confidence in the device
• Reduces wastage from production of medical devices, and
• Leads to improvements in product quality, processes and design
• Ensures adherence to product specifications
• Most importantly, avoids a host of embarrassing and time-consuming activities such as Warning Letters, 483’s, inspections, penalties and the like.

In relation to which regulatory requirements should medical a device process be validated?A medical device process validation has to be conducted in relation to four important standards:

• The FDA’s Quality System Regulation
• ISO 9001:2008
• ISO 13485:2003
• Relevant and appropriate OSHA standards

What to validate and what not to?Although this question appears complex, the guidelines issued by the Global Harmonization Taskforce (GHTF) serve as a good indicator for this question. It states in simple and unequivocal ways that any process whose output is verifiable, and when this verification suffices and is cost effective, does not have to be validated. Every process that does not meet this criterion has to be revalidated. The Medical Device Quality Systems Manual provides more details on this matter.

When to validate a medical device process?Medical device process validation has to be done both during production and after release, depending on the product design and release. This means that medical device process validation is carried out both when a new product is being manufactured or when there is a need to revise the process, and when defects are discovered after the release into market, when the device has to be recalled and validated.