MDD 93/42/EEC : MDR 2017/745 Technical Documentation Reviews

Review of your Technical Documentation for the New MDR 2017/745

  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.      

New MDR 2017/745 Technical Documentation Review - Gap Analysis Report

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

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).

  

Reviewer Experience and Qualifications

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.

Existing MDD Directive 93/42/EEC as amended by 2007/47/EC Documentation

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.

CONFIDENTIALLTY is assured

All communications with us and the subsequent Review and Result of your Documentation, will be treated at all times in the strictest confidence.

absolute confidence is assured, at every stage of an enquiry

Please contact us for a Quotation in absolute confidence

Thank you for your interest in our Services....

Someone will respond to you as soon as possible, usually within 24 hours.

Medical Device Regulatory Solutions

MDRS-EU, ALTRINCHAM, Cheshire WA15 7SN, GB

0161 870 6751