We can provide you with reassurance that your Technical Documentation meets all the necessary requirements of the New MDR 2017/745 European medical device regulation.
We can provide you with reassurance that your Technical Documentation meets all the necessary requirements of the New MDR 2017/745 European medical device regulation. Our comprehensive New MDR 2017/745 gap analysis, will review your current Technical File or Design Dossier, and will highlight any gaps or deficiencies in your documentation and processes. These deficiencies will be presented in a clear and easy to follow Gap Analysis Report, along with recommendations on how best to address the issues.
The Detailed Review will include all of the following areas:
● Clinical data according to MEDDEV 2.7/1 rev4;
● Information to be supplied by the manufacturer;
● Design & manufacturing data;
● Benefit / Risk analysis & risk management data;
● Post Market Issues: processes and data;
● Product Verification and Validation;
● Device description;
● GSPR's - (General Safety & Performance Requirements).
The review of your documentation is by a Specialist in Medical Device Regulations, with 40 + years of experience, including thousands of hours Auditing experience (both On Site at manufacturing facilities and Desk Top Technical File reviews) with United Kingdom Notified Bodies over many years.
Your existing Technical File or Design Dossier or Design File will still be valid until 2019 or even later, in some cases.
We can review your compliance data and give you the assurance you need, if you have any doubts about your current compliance.
All communications with us and the subsequent Review and Result of your Documentation, will be treated at all times in the strictest confidence.
Someone will respond to you as soon as possible, usually within 24 hours.
MDRS-EU, ALTRINCHAM, Cheshire WA15 7SN, GB