Get your passport for the european market !
The CE mark is the compulsory passport for your products launching on the European market.
Its obtaining requires an often complex and long approach.
Specialist for medical device CE marking
With more than 15 years of experience, CILLEO proposes you a complete service :
● to check the applicable regulations and normative context,
● to determine the directive and the evaluation procedure applicable to your products,
● to realize the risk analysis of your products with recognized methods (ISO 14971 standard for the medical devices or AMDEC),
● to write the technical report,
● to determine the tests to be done,
● to check your products conformity,
● to choose the notified body,
● to validate your product instruction manual.
● to determine and implement the procedure of post-market follow-up
Our rigorous and tested methodology will help you to constitute a complete file, showing the compliance of your products with the required standards and their level of safety during their whole life duration.