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, ATRC is able to support you with optimised solutions for your biocompatibility testing, including:
tailor-made designs especially for biodegradable and borderline products
compliant with the latest ISO and USP guidelines
administration routes in line with the the clinical use
broad range of experimental and farm animals
animal handling according to the 2010/63/EU guideline 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.