As per European Medical Device Regulation (EU MDR) a Technical File is prepared by the legal manufacturer to prove that a Medical Device complies with the essential safety and health requirements. Technical Files are required for all risk classes of medical devices such as Class I, Is, Im, IIa, IIb, and III. Technical File or Design Dossier must be prepared to demonstrate Clinical Safety, User safety, performance, efficiency by incorporating device photographs and diagrams, clinical and preclinical studies, Post market studies, Risk analysis etc. A Technical File can be compiled in any of the official languages of the EU depending upon the notified Body you selected. However, English is the most commonly used language by non-European manufactures. An up to date electronic copy of the file needs to be kept available with the manufacturer, Notified Body and with the European Authorized Representative.
Technical Documentation of Class I, Is, Im, IIa, IIb, and III medical devices will be thoroughly reviewed along with Clinical Evaluation Rev 4 reports by Notified Bodies as part of the CE Certification process. Due to reasons manufactures will look for efficient cost effect technically sound consulting companies to prepare, submit and answer to Notified Body..
QARA is a product designed to serve customers worldwide, to successfully prepare and submit technical file for Class I, Is, Im, IIa, IIb, and III medical devices with the guarantee of CE Certification. Our services are delivered completely by remotely by using cloud technology. Cloud technology helps to reduce the travelling and allied expenses. .
QARA expert assistance online is very economical and fast. Organizations interested to work with us can appoint one dedicated person to interact with 21 CFR 820 consultants by telephone/skype/G talk & Email.
QARA and its team makes it true by ONLINE and ONSITE Support
It is Fast, Economic, User Friendly employees in charge of from the organization.
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What we do for successfull Technical File submission with Notified Body?
If you are looking for CE Marking Technical File service please contact us. We are located in Germany, India & USA.
Medical Device Technical File package Fees
Kindly refer Medical Device CE Marking Page