ISO 13485 & FDA QMSR Documents for Medical Device Companies
Editable procedures, complete QMS packages and validation protocols, written by a former Senior Director of Regulatory Affairs and used in FDA and notified-body audits in 45 countries. Use them on paper or import them into your eQMS.
Practical documents. Focused regulatory support.
1. Choose Your Scope
Compare a complete quality system, individual procedures, or validation protocols. Check each listing for its document scope and included files.
From Download to Working Document
2. Tailor Your Documents
Use the editable documents as a starting point. Add your organization’s details, responsibilities, process requirements, and study-specific acceptance criteria.
3. Review and Implement
Review and approve documents through your own quality system. Need help with implementation or a technical question? Contact A.P. Lyon about consulting support.
About A.P. Lyon
A.P. Lyon provides quality-system documentation, validation protocols, and regulatory consulting for medical device organizations. Our work connects documentation with the practical needs of implementation, review, and ongoing use.
Whether you need a coordinated system or support for a specific project, start with the relevant documents and tailor them to your intended use. Our consulting services can help you identify gaps and plan the next steps.
Editable documents. Practical guidance. Support for your next step.