AURIGON – YOUR QUALIFIED PARTNER FOR YOUR MEDICAL DEVICE TESTING
The diversity of medicinal device products and product classes requires flexibility and expertise to bring the desired medical device to the market.
To ensure product safety, medical device manufacturing requires a high level of process control in line with the classification of the device; higher risk to the patient means more controls for the manufacturer.
With its interdisciplinary team of toxicologists, veterinary surgeons and certified pathologists, Aurigon is able to support you with optimized solutions for your biocompatibility testing, including:
- tailor-made designs compliant with the latest ISO and USP guidelines,
- routes of administration in line with clinical use,
- a broad range of experimental animals,
- animal handling according to the European directives and ISO standards, and under the control of the Institutional Animal Care and Use Committee (IACUC),
- performance of studies in a controlled GLP/GMP environment and fully GLP- and USP-compliant for US registration.
Aurigon is certified according to ISO 13485 as well as GLP and GMP, ensuring these studies are conducted under a quality management system specific to medical device testing.
See also our Medical Device-related services at the following link: