Quality

At Exact Medical, we treat every project with the same unwavering commitment to quality.

Our systematic approach to quality assurance gives Exact Medical the confidence that every step — from material sourcing, validation, production and packaging to delivery — is precise and achieves our customers’ expectations.  We can say with confidence we deliver the right product every time.

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A singular focus on quality through every production run.

Product Credentials

    • FDA 510(k) Premarket Notification
        • K121919
        • K120045
        • K111535
        • K101598
        • K101688
        • K101689
        • K101593
        • K211969 

    • FDA Premarket Notification meets the AAMI PB:70 Level 1 through 4 standards for Gowns and Drapes.

 
  • ISO 10993 Biocompatible
  • ISO 11135 Sterilization Validation
  • ISO 11607 Packaging for Terminally Sterilized Medical Devices
  • AAMI PB:70 Liquid Barrier Compliant
  • EN13795 Barrier Compliant (Standard/High Performance)
  • 16CFR1610:2007 – Compliant Flammability Rating
  • ISO 13485:2016 Quality Management System
  • CE certified under Medical Device Regulation