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Medical Devices

The conformity assessment of medical devices is a complicated area with a high density of regulation. To demonstrate safe CE compliance of your products, I offer the following services:

  • Preparation of complete technical documentations
  • Creation of individual documents (e.g. instrucitions for use or processing instructions)
  • Consulting on specific issues of conformity assessment (e.g. product labeling, OEM procedure)
  • Development of risk analysis
  • Expert's opinions and assessments
  • Seminars and lectures (e.g. training of medical device consultants)
  • Consulting for the operation, use and maintenance of medical devices and creation of required documentation (e.g. inventory, equipment books)