REGULATORY

Keep Your Worldwide Product Sales Alive and Well

Conforming to medical device regulations is critical to the successful marketing of medical products. Ensure your company’s conformance to current and new regulations.

Surgical Technologies, Inc., is experienced with…

  • Medical Device Directive (MDD)
  • ISO 13485 Certified
  • In Vitro Diagnostic Directive (IVDD)
  • U.S. Food & Drug Administration (FDA)
  • 21 CFR 820 (Quality System Regulation)
  • JPAL Certified Manufacturer

Services:

  • US Agent (FDA)
  • European Authorized Representative

 

Our STI team specializes in LEAN manufacturing which results in increased capacity, cost savings and work cell efficiency.

ISO 13485 Certified