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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.
Compliant
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 midterm 2020.
Update Up To Date
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 accordingly adjusted to meet current regulatory standards until midterm 2020 when MEDDEV 2.7.1 revision 4 and the MDR 2017/745 become legally effective.
Short-Term
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 a timely manner.
IASON consulting is your number one partner when it comes to compiling Clinical Evaluation Reports for your medical device and its accessories.
Clinical Data
IASON consulting gathers, evaluates, and analyses significant scientific literature out of current state of the art medical, toxicological and pharmacological databases.
Evidence
We collect strong and significant clinical evidence on devices concerning their respective achievements of their purposes and patient safety.
Compilation
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.