We are aware technical documentation is a crucial starting point for a quick, smooth and effective CE certification process.

But submitting correct and complete technical documents is not easy for medical devices manufacturers, which must consider different aspects, from a regulatory point of view.

  • What documents must be submitted?
  • What are main contents to consider?
  • How to draw up the documentation?
  • And finally, how to submit them?

ECM provides the Ultimate Guidelines to submit a complete, correct Medical Device Documentation to your Notified Body!!

Documentation best practices identified by ECM in the Guidelines help manufacturers to save time and costs spent in further reviews and adjustments, which often cause important delays in the very first step of the CE certification submission process.

ECM Guidelines are the useful tool for a successful submission of medical device documentation to your Notified Body.

ECM Guidelines are available for free, on request.

If you would like ECM to email you a copy of our Guidelines for saving time and resources when submitting Technical Documentation, click here