The requirements for medical devices in terms of risk management, purity and biocompatibility have increased continuously in recent years. We are happy to support you with regard to regulatory obligations (EU-MDR) and normative requirements (DIN EN ISO 10993).
The regulatory demands for manufacturers and distributors of medical devices nowadays are very extensive with regard to the materials used (chemical characterisation), the cleaning process (validated procedures), biocompatibility (qualified screening procedures, Leachables&Extractables) or the documentation on the life cycle of the products (aging tests).
We have been determining sterilization residues (EO, ECH Formula) according to DIN EN ISO 10993-7 for well-known European and international manufacturers for many years.
Thanks to our extensive, chemical-analytical portfolio and the expertise of our employees, we develop tailor-made solutions with you for your product, in order to meet these requirements at the best possible price-performance ratio.
We can offer you the determination of organic sum parameters mentioned in the ISO 19227, such as TOC (GC-WLD method according to Ph. Eur.) and THC (GC-FID method according to DIN EN ISO 9377), with methods that are used and accepted by national and international authorities.
The measurement of inorganic parameters (e.g. salts, elemental impurities) using ion chromatography and ICP-MS is also one of our core business areas of expertise.
The entire scope of the methods mentioned in DIN EN ISO 10993-18:2021 for the determination of SVOC, VOC, NVOC is possible with us.
Particulate residues from production or from transport simulations can be quantified and identified by us.