Medical Device Process Validation Procedure
The Medical Device Process Validation Procedure provides guidance on medical device process validations. The ISO 13485:2016 Process Validation Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.
ISO 13485:2016 aligned
FDA QMSR aligned
MS Word Format
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The Process Validation Procedure provides guidance on medical device process validations. The Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.
Medical Device Process Validation Procedure - Overview
The Process Validation Procedure is applied to medical device manufacturing processes where the output of a process cannot be verified through inspection or testing. The Process Validation Procedure provides instruction for determining when process validation is required, validation pre-requisites, and overall strategy. The procedure also includes information on worst case product selection, validation lots, test methods and acceptance criteria.
Medical Device Process Validation Procedure - Compliance
The Process Validation Procedure is FDA QMSR and ISO 13485:2016 aligned.
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Regulatory framework
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
