Certania
Med Tech
Our MED TECH segment covers a wide range of specialised services that ensure the safety, performance and regulatory compliance of medical devices and pharmaceutical applications. The focus is on microbiological and physicochemical laboratory tests, sterility and endotoxin testing, biocompatibility testing, toxicological and pharmacological analyses, and individually developed test procedures. In addition, we offer validation and qualification services for processes, devices and clean rooms, as well as risk analyses, troubleshooting for contamination, documentation for market approvals and technical training.
Another key component is comprehensive mechanical testing for implants and medical instruments. This includes high-precision stress and service life testing in accordance with standards such as ASTM, ISO and DIN, as well as tailor-made test scenarios for special applications. Engineering services, the creation of biomechanical documentation and support with international approval procedures are also offered.
For a humanity in certainty
MedTech
Accredited mechanical testing and technical services for implants and medical devices are the focus of our services: Since 2007, we have been supporting the approval process with tests according to ASTM, ISO and DIN standards as well as customised test setups. We carry out load, durability and functional tests and prepare biomechanical documentation for regulatory procedures. With state-of-the-art equipment and international accreditation, we guarantee safe, reliable and standard-compliant product evaluations.
Since 1995, our multidisciplinary teams have been working to ensure the quality and conformity of medical and pharmaceutical products with practical solutions. We combine microbiological and physico-chemical testing, biocompatibility and toxicology testing, process validation, qualification of devices and cleanrooms as well as sound regulatory advice. With over 500 customers – from start-ups to international manufacturers – we are active worldwide and fulfil the strictest quality standards.