Quality
Admedes is dedicated to providing the highest quality products possible. We continually strive for excellence in product performance, work place satisfaction, and harmony with the environment. We are committed to a continuous improvement program that ensures quality is an individual employee responsibility. We strive to achieve total quality satisfaction to our customers from the first inquiry right through to volume manufacturing.
Quality Assurance is provided through audit support, support for PMA, IDE & 510k approval processes.
The company is certified according to DIN EN ISO 9001 - 2000 and DIN EN ISO 13485 - 2003.
Our Quality Management System covers FDA requirements like the current GMP QSR guidelines (21 CFR
Part 820). Admedes is also an FDA registered facility.
As the recognized leader for OEM Nitinol components, to assure that our high quality standards are maintained, we have stringent inspection criteria to choose raw material sources and vendors. Only tubing material which meets our specification will be used in component manufacturing. We execute controls in each manufacturing step, and perform functional testing along with 100% visual inspection of each individual device. Our in-house SEM and micro-analysis capability are standard tools we use for quality assurance.
We strive to achieve total quality satisfaction.