CERTIFIED MANUFACTURING PRACTICES
Synovis manufacturing facilities are US FDA-registered and certified by our Notified Body to ISO 13485:2003 and are subject to regular inspections from both FDA and our Notified Body.
The Synovis Quality System ensures that all manufacturing operations are conducted in accordance with current Good Manufacturing Practice as defined in the USA Quality System Regulations (21 CFR 820) and the international ISO 13485 standards.
Synovis manufacturing facilities and processes are in compliance with, but not limited to, the following Regulations and Standards:
- FDA 21CFR Part 820
- EU MDD 93/47/EEC
- Canadian Medical Devise Regulations
- Australian Medical Device Regulations
- EDQM Certificate of Suitability
- ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14971 Medical devices - Application of risk management to medical devices
- ISO 10993 Biological Evaluation of Medical Devices-Part I: Guidance on Selection of Tests
- ISO 14630:2008 Non-active Surgical Implants – General Requirements
- ISO 15223-1:2007 Medical devices – Symbols To Be Used With Medical Device Labels, Labeling And Information To Be Supplied
Synovis Surgical Innovations, a leader in tissue technology and innovative surgical tools.
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