Quality

We are more than aware of the responsibility of quality in medical device manufacturing.

Quality.

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. 

Maintaining a culture of quality

It’s no accident that our focus on quality permeates every level of the company. New employees receive extensive training before beginning their jobs. We also provide ongoing training to refresh and further our employees’ understanding of the parts they play in producing the finest medical devices available.

Quality-verification processes

Our quality system offers unparalleled oversight of the production process − from material sourcing to product delivery. We are the recognized leader in OEM nitinol component manufacturing, in part because of the care we take in selecting raw material sources and inspecting each piece we receive. As products move through design for manufacturing and into production, we test, inspect and validate.

Each individual device undergoes functional testing, 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
Quality

At ADMEDES, quality is a mindset demonstrated through countless actions that occur at every step − from initial prototyping through manufactured product delivery.