Risk Management Procedures Bundle | ISO 13485 | FDA QMSR
Bring lifecycle, design and production risk activities together with four editable medical device procedures: Risk Management, Design Risk Management, Process Risk Management and Design Analysis. Related Word and Excel forms support planning, risk evaluation, control and analytical methods.
Supplied as editable Microsoft Word and Excel documents with related forms as a digital download.
Lifecycle, design and process-risk document scope
Risk Management Procedure: risk-management planning, reports and files, with supporting forms.
Design Risk Management Procedure: identifying and documenting design risks, with Excel forms.
Process Risk Management Procedure: identifying and documenting production process risks, with Excel forms.
Design Analysis Procedure: DFMECA, PFMECA, House of Quality (HOQ) and Fault Tree Analysis (FTA), with related forms and study ground rules.
Together, these procedures support risk analysis, evaluation, controls and ongoing review.
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.
Individual documents in this bundle
Bundle value: The 4 included procedures total $576 when purchased individually at current prices. This bundle is $499, saving $77 (13%). Related forms are included as described above.
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 Risk Management: Design and Process Risks for workflow guidance, a checklist and common mistakes.
