Quality: Now™
A true quality-system-in-a-box™...
- Comprehensive set of SOPs, Forms, and Guides (guidance documents)
- Intended exclusively for small and start-up medical device manufacturers
- Empowers manufacturers to rapidly deploy, implement and maintain a compliant, robust quality system
- Compliant with both FDA quality system regulations and ISO voluntary regulations
- Implements ISO 14971 standard for risk management
- Service contract provides for quarterly audits of various aspects of the quality system to document and assure compliance
Track record...
- Currently undergoing beta-testing and evaluation
- Design Controls, Document Controls and Configuration Management modules reviewed and APPROVED by FDA Office of Compliance
Downloads:
- SOP: Deciding Whether to Submit a 510(k) Submission >>>
- FORM: 510(k) Decision Tree >>>
- White Paper: DESIGN CONTROLS: Small and start-up medical device companies need to be compliant with the FDA quality system regulations (QSR)
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