WE ARE KEENLY AWARE THAT QUALITY IS CRITICAL IN MEDICAL DEVICE MANUFACTURING.
No industry faces a higher mandate for quality than medical device manufacturing. At ADMEDES, we understand that and we are proud that our history proves our commitment to quality. To date, several million ADMEDES products have been implanted in patients.
As an FDA-registered facility, we operate under the most stringent guidelines for quality assurance. Each customer receives an individualized inspection plan that conforms with regulatory directives and company requirements.
Our quality system offers unparalleled oversight of the production process − from material sourcing to product delivery. As products move through design for manufacturing and into production, we test, inspect and validate.
Each individual device undergoes functional testing, and dimensional and visual inspection before release.
- FDA registered and audited
- Compliant with current FDA guidelines, including GMP QSR guidelines (21 CFR Part 820)
- Support for PMA, IDE & 510k approval processes
- DIN EN ISO 13485 certified