USA : +1 630 696 1293   INDIA : +91 994 591 2081    GERMANY : +49 216 1990 8831    Email: enquiry@i3cglobal.com

Online Documentation for Medical Device Technical File as per EU MDR




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.

  • We develop the Technical File for you. We handover the Techncial File after Certification.
  • No worries, pay after Certification!!!
  • No matter Size and team strength of the organization, we have the sufficient manpower. We only need a technical person from your company to coordinate with our team.

THE BEST AND EFFECTIVE WAY TO GET YOUR MEDICAL DEVICE CE CERTIFIED BY ANY NOTIFIED BODY OF YOUR CHOISE.

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.

No matter where you are OR where we are....

Contact us to get started.

 





 

What we do for successfull Technical File submission with Notified Body?

  • Detailed study of device and Identify relevent standards and MDR requirments.
  • Draft the Medical Device Technical File
  • Identify the Notified Body and Submit Technical File
  • Coordinate with Notified Body till review comments accepted
  • Support for EN ISO 13485:2016 if required by client
  • We do GAP analysis of Technicla File if asked by client
  • We do CER docuemntation as per MEDDEV 2.7/1 Rev.4 as part of Medical Device Technical File
  • We provide EN ISO 14971:2012 risk analysis as part of the Medical Device Technical File

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

 

Contact Us

LiveZilla Live Chat Software

call me back


enquiry@i3cglobal.com

request for quote

 
LiveZilla Live Chat Software