Planning the Route to CE Certification – Planning, Developing and Realising Medical Devices



The manual “Planning, Developing and Implementing Medical Devices” describes the complete development process of a medical device, from brainstorming to CE marking and application through all legally defined phases.

The focus is on structured product development with parallel consideration of risk management, usability and clinical evaluation. Comprehensive and practical, it is shown which individual tasks are incurred and in what order they should be done.

The authors of the papers are proven experts, experts in the legal situation and even committed developers of successful medical devices. They deliver fast-paced application knowledge, concrete instructions and practical examples.

This information puts everyone involved in product development in a position to make the entire development process of a medical device faster, safer and more economical.