Quality and Regulatory
Quality first, everything else second.
Our quality objectives are simple. Ensure compliance with all FDA, ISO, and MDD regulations while implementing customized validation and quality assurance systems that meet each of our customers’ specific requirements.
The Freudenberg Medical Global Quality Team has extensive experience with Class I, II and III Medical Devices and uses a range of methods and tools to support elements of the Quality System such as Product Development, Product Realization, Post Market Surveillance and Risk Management.
Freudenberg Medical has established, documented, and implemented a quality and environmental management system that is reviewed continuously for effectiveness in accordance with ISO 13485, MDD EC Directive 2007/47/EC, FDA QSR 21 CFR part 820, and Canadian Regulations.
Our dedication to quality encompasses:
- FDA registered facilities in California, Indiana, Costa Rica, Ireland
- cGMP and QSR compliant globally
- ISO 13485 certification
- European MDD 93/42–ECC
- CMDCAS Health Canada
- Regulatory 510(k) and CE submittal process
- CDPH licensed medical device manufacturer
- ISO Class 7 & 8 Cleanrooms
- Climate-controlled metrology laboratory
- Test method development, first article inspections, Gauge R&R
- Electronic record keeping