Quality
Paragon Medical emphasizes continuous improvement and permanent defect prevention through a quality system that is comprehensive, data-driven, and cGMP compliant.
ISO 13485:2016
Paragon Medical facilities are ISO 13485:2016 compliant
- Paragon Medical – Bloomingdale, IL USA (PDF)
- Paragon Medical – Bridgeport, CT USA (PDF)
- Paragon Medical – Changzhou, China (PDF)
- Paragon Medical – Dayton, OH USA (PDF)
- Paragon Medical – Indianapolis, IN USA (PDF)
- Paragon Medical – Mansfield, MA USA (PDF)
- Paragon Medical – Pierceton, IN USA (PDF)
- Paragon Medical – Siechnice, Poland (PDF)
- Paragon Medical – Smithfield, UT USA (PDF)
- Paragon Medical – Southington, CT USA (PDF)
- Paragon Medical – Warsaw, Innovation Center, IN USA (PDF)
FMA Japan
- Paragon Medical – Bridgeport, CT USA (PDF)
ISO 9001:2015
Regulation (EU) 2017/745
- Paragon Medical – Bridgeport, CT USA (PDF)
FDA Registered
- Paragon Medical – Bloomingdale, IL USA
- Paragon Medical – Bridgeport, CT USA
- Paragon Medical – Changzhou, China
- Paragon Medical – Dayton, OH USA
- Paragon Medical – Indianapolis, IN USA
- Paragon Medical – Mansfield, MA USA
- Paragon Medical – Pierceton, IN USA
- Paragon Medical – Siechnice, Poland
- Paragon Medical – Smithfield, UT USA
- Paragon Medical – Southington, CT USA
Clean Room - ISO 7, Class 10,000
- Paragon Medical – Mansfield, MA USA
Clean Room - ISO 8, Class 100,000
- Paragon Medical – Bridgeport, CT USA
- Paragon Medical – Smithfield, UT USA
- Paragon Medical – Southington, CT USA