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 
        • K222460

    • 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
 

Testimonials

“Exact Medical understands what I need. They help me provide more to my customers, which gives me an extra competitive edge in a tough market.”
“Exact Medical is much more than a standard contract manufacturer. We’re getting better quality, better service, and stronger capabilities than we’ve ever received.”
“Continuous trust – that’s what Exact Medical has always delivered for us. Knowing that next time will be the same quality as this time.”
“Exact is completely focused on meeting the needs of OEMs like us. While others are busy trying to deal with multiple channels, they’re delivering everything we ask for.”
“The facilities in China are clean, well-lit, and organized. What’s more, the quality control has been top-notch.”
“I do business with Exact Medical because they make a great product, have reliable delivery times, and competitive pricing.”

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