Quality Assurance Services
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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Services Overview
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
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