A professionally developed ISO 13485 Documentation Toolkit containing complete SOPs, templates, forms, logs, checklists, validation protocols, risk management files, CAPA systems, supplier controls, complaint handling, PMS documentation, sterilization records, audit tools, and production quality records for medical device manufacturers.
Designed for startups, manufacturers, consultants, regulatory teams, and compliance professionals seeking rapid implementation of a compliant Medical Device Quality Management System (MDQMS).
Build and implement a fully compliant Medical Device Quality Management System using this professionally structured ISO 13485:2016 Documentation Toolkit.
This comprehensive package includes 122 ready-to-use SOPs, templates, forms, logs, checklists, validation protocols, and regulatory documentation aligned with:
- ISO 13485:2016
- ISO 14971 Risk Management
- IEC 62304 Software Validation
- IEC 62366 Usability Engineering
- ISO 11135 / ISO 11137 Sterilization
- EU MDR 2017/745
- FDA 21 CFR Requirements
- ISO/TR 20416 Post-Market Surveillance
The toolkit is ideal for:
- Medical device manufacturers
- Startups preparing for certification
- Regulatory affairs teams
- Quality assurance professionals
- ISO consultants
- Contract manufacturers
- MDR/FDA compliance projects
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