Quality

Our quality process ensures that your device will perform as required, works in a safe manner and meets your development schedule. Our process is ISO 13485 certified and is rigorous but not burdensome. It can be used stand-alone or in conjunction with your system. If needed, we can also seamlessly utilize your system alone.

  • Our quality management system follows strict guidelines which eases the process of 510K & PMA submissions

  • Meets FDA requirements established in 21 CFR 820.3 and 21 CFR 820.30

  • Designed for Class l, ll and III medical device development

  • ISO 13485 certified

  • ISO 9001 compliant

  • Regulatory and agency compliant

  • FDA, RoHS, UL, EMC, EMI, FCC, DHF

  • Consent decree remediation and product support

  • Project work plan development

  • Risk management and contingency planning

Get Garrett’s ISO Certificate Here







 

Case Studies