Quality

Satisfying your needs and expectations the first time, every time

Quality is always our focus at Freudenberg Medical. We work closely with the companies we serve to implement customized validation and quality assurance systems. Our objectives are to ensure compliance with all FDA, ISO, and MDD regulations, and to fulfill each of our customer’s specific requirements.

The Freudenberg Medical Quality team has extensive experience with Class I, II, and III Medical Devices and uses a range of methods and tools, including IQ, OQ, PQ, FMEA, PFMEA, and Design of Experiments (DOE) to support in risk processes.

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.

Freudenberg Medical’s 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

Certifications

Freudenberg Medical operations around the world have received ISO and FDA certifications.

ISO 13485

Carpinteria, California USA
Baldwin Park, California USA
Jeffersonville, Indiana USA
Minnetonka, Minnesota USA
Gloucester, Massachusetts USA
Alajuela, Costa Rica
Kaiserslautern, Germany
Würselen, Germany (Hemoteq AG)
Shenzhen, China
Carrick-on-Shannon, Ireland (VistaMed)
Spiddal, Ireland (Cambus Medical)

FDA Registration

Carpinteria, California USA – FDA registered
Baldwin Park, California USA – FDA registered
Jeffersonville, Indiana, USA – FDA registered
Alajuela, Costa Rica – FDA registered
Carrick-on-Shannon, Ireland – FDA registered