Are you a medical device manufacturer and your technical documentation is ready? You want to submit it now? Here you will find important information on this.

In order to bring a medical device to market, manufacturers must apply the applicable conformity assessment procedures to their medical devices. For the submission of the technical documentation, DQS Medizinprodukte GmbH has prepared an information based on the requirements of the (EU) 2017/745 Medical Devices Regulation (MDR) Annex II and Annex III.

MED Präsentationsfolien

More about submission of a technical documentation according to EC Regulation 2017/745:

  • Administrative Information
  • Technical Documentation
  • Bibliography
Michael Bothe

Michael Bothe heads the certification decision board for Active Medical Devices and is also a lead auditor. He is also involved in standardization at the German Institute for Standardization (DIN) and the German Commission for Electrotechnical, Electronic & Information Technologies (DKE) and coordinates continuing education activities for customers. His interests include integrated audits as well as process optimization of conformity assessment procedures.