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 according to MDR
• Creation of individual documents (e.g. instrucitions for use or processing instructions)
• Consulting on specific issues of conformity assessment (e.g. product labeling)
• Development of risk analysis
• Expert's opinions and assessments
• Seminars and lectures (e.g. training of medical device consultants)