ISO 13485 Quality Management System Manual
- ISO 13485:2016 Compliant
- FDA QSR 21 CFR Part 820 Compliant
- Medical Device Regulation (MDR) EU 2017/745
- MS Word and PowerPoint Formats
- Instant Download Digital Content
ISO 13485 Quality Management System ManualThe ISO 13485 Quality Management System Manual serves as the top level document governing all quality system standard operating procedures required to comply with ISO 13485:2016 and the FDA QSR 21 CFR Part 820.
The quality management system manual can be easily adopted to match your companies unique activities and markets served. For more information about our ISO 13485 Quality Management System Manual contact us at [email protected] RELATED LINKSMedical Device Quality Management System BASE
Medical Device Quality Management System BASE PLUS Medical Device Quality Management System DESIGN Medical Device Quality Management System DESIGN PLUS Medical Device Quality Management System MANUFACTURING Medical Device Quality Management System MANUFACTURING PLUS |
ISO 13485 Quality System Manual
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Medical Device Quality Management System | BASE PLUS SYSTEM
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The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
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