Medical Device Process Validation Procedure
Plan and document medical device manufacturing process validation with this editable Process Validation Procedure. It helps determine when validation is needed and addresses prerequisites, worst-case product selection, validation lots, test methods, acceptance criteria and revalidation.
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Supplied as one editable Microsoft Word document in a digital download.
Manufacturing process validation planning
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.
Validation planning and protocol execution
Process qualification, revalidation and personnel training
Validation numbering, raw data and final report records
Standards and frameworks addressed: ISO 13485:2016; FDA QMSR.
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.
Use the Validation Protocol and Report Procedure for qualification document structure and the Installation Qualification Procedure for equipment installation checks.
See the MANUFACTURING PLUS Quality Management System
For mold-process tooling development and qualification, including example OQ and PQ protocols, see the separately sold Injection Mold Validation Procedure. Choose the document that matches the process you need to validate.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Process Validation: Protocols, Statistics and Mold Processes for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in ISO 13485 Process Validation Procedure Bundle. Explore the bundle for the related documents.
Process Validation Procedure vs Bundle vs Qualification Protocol
