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Manufacturing and distributing medical devices and medical device accessories on the European market require the preparation and maintenance of a Clinical Evaluation Report in compliance with MEDDEV 2.7/1 revision 4 and MDR 2017/745.
We provide medical device companies with compliant, quick, and long-term expertise concerning the creation of current and future mandatory documents for market entry and for devices already available on the market.
CERs by IASON consulting are regularly created in compliance with MEDDEV 2.7/1 revision 4 and the MDR 2017/745 becoming legally binding during mid-term 2020.
As of 2017 MEDDEV 2.7/1 revision 4 and MDR 2017/745 replace MEDDEV 2.7/1 Rev. 3. Already existing CERs need to be adjusted accordingly to meet current regulatory standards until mid-term 2020, when MEDDEV 2.7.1 revision 4 and the MDR 2017/745 become legally effective.
If you need a new CER or a CER update according to the latest developments within the medical device and medical device accessory sector, make sure to contact IASON consulting. Our experienced and multidisciplinary staff will have your CER ready in no time.
IASON consulting gathers, evaluates, and analyses significant scientific literature out of current state of the art medical, toxicological and pharmacological databases.
We collect strong and significant clinical evidence on devices concerning their respective achievements of their purposes and patient safety.
Following the review of clinical data from existing literature, clinical experience, clinical trials, or any combination of the three our expert consultants compile your CER or CER update according to accurate EU requirements, currently MEDDEV 2.7/1 revision 4 and the MDR 2017/745.
Please feel free to contact IASON consulting and its team of expert consultants in the field of medical device and medical device accessory CER compilation to receive more detailed information on your specific topic.