Product Stability Shelf-Life Procedure | ISO 13485 | FDA QMSR
Plan and document evidence for a medical device shelf-life claim with this editable Product Stability and Shelf-Life Procedure. It guides stability protocols, accelerated aging and concurrent real-time studies, testing after aging, review of results and support for a labeled expiration period.
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Supplied as one editable Microsoft Word document in a digital download.
Shelf-life evidence, aging and stability studies
The Shelf Life Procedure provides instruction on conducting accelerated aging and concurrent real time aging studies. The Shelf Life Procedure includes guidance on the preparation of product stability protocols and considerations, and the required content of a stability protocol.
The shelf-life workflow defines what product characteristics and sterile-barrier properties must remain acceptable through the proposed life. It provides for a study protocol, real-time or accelerated aging where appropriate, interim testing, documented results and a final engineering review. The approved evidence is then used to establish or revise the labeled expiration period, with new products evaluated before commercial release.
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 Label Review and Approval Procedure to review the resulting expiration information on labels and instructions for use. Both procedures are included in the Medical Device Labeling Procedure Bundle.
For a focused sterile-barrier packaging study plan with Q10 calculations, sample allocation and post-aging test records, see the separately sold Accelerated Aging Study Protocol. The shelf-life procedure addresses the broader review and approval of stability evidence and expiration claims.
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 Shelf Life and Accelerated Aging: Define the Claim First for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Medical Device Labeling Procedure Bundle. Explore the bundle for the related documents.
