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Strategic input into device development


Medical devices which are coated with an active ingredient are an important alternative for the treatment of severe medical conditions like cardiac infarction. Several new drug-coated devices with novel active ingredients will be developed in the near future.

The classical (standard) development for uncoated devices is complicated by the necessity for the characterisation of the drug compound.

We have the knowledge to help develop the right strategy and support finding the right contacts for this exciting class of new devices.

Our services include:

  • creating, together with our customers, an optimised development
  • strategy
  • defining and selecting the right notified body
  • discussing, defining, and selecting a regulatory authority
  • assisting with the definition of all legal steps in obtaining a CE marking
  • clarifying manufacturing issues