Medical Devices
Medical Devices

Over the past 25 years the WTC-team has specialized in the pre-clinical testing of medical devices in accordance to Council Directive 93/42/EEC and the verification of the biocompatibility of medical devices according to ISO 10993-1.
As neutral third party service provider between the suppliers of raw materials and intermediates used in the manufacture of medical devices, and the manufacturer of the medical devices, we can get access to (confidential) compositional information based on secrecy agreements signed with the involved parties. This information forms the basis of the safety evaluation and of the development of a likely test program for evaluation of the biocompatibility of the medical device.

 

Services
  • Evaluation of the biocompatibility in accordance with ISO 10993-1
  • Assessment reports
  • Compliance certification
  • Literature search for safety data and data  collection
  • Proposal of test program, and coordination and scientific monitoring of studies at the testing facility
  • Development of strategies for the safety evaluation
  • Expert reports
  • Compilation of technical information files for record tracking
  • Coordination and archiving of technical information for authority inspection
Safety Testing Services
  • Conception, execution and management of biocompatibility testing as needed at a testing facility of our clients’ choice:
    • Haemocompatibility
    • Migration / leaching studies
    • Development  / validation of analytical methods
    • Mutagenicity studies
    • Toxicity studies
    • ADME studies
  • The tests will be performed according to the relevant international test guidelines, e.g. OECD, EC, FDA, European Pharmacopeia, USP, etc.
  • Project Management and scientific monitoring of studies.