I will do iso 13485, ce mark with rep, doc, eudamed and mdr documentation

Looking for ISO 13485, CE, EU REP, EUDAMED/ SRN & MDR Documentation.

Then I can help you.

I am sure that it's a challenge to prepare documentation and get ISO 13485, CE, EUDAMED/ SRN & MDR But these are mandatory Requirements to place medical devices in European Market.

ISO 13485:2016 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

The European Authorized Representative (EC REP) performs certain duties under the European Medical Devices Regulations and acts as the legal interface between the Medical Device manufacturer and the EU Authorities.

Under the new MDR (EU) 2017/745 Authorized Representatives (EC Rep) have greater responsibilities and take on significantly more risk and liabilities, therefore you can expect your representative to scrutinize your documentation more thoroughly.

The declaration of conformity certificate will also be provided to you.

Drop a message and discuss with our experts.

• Note: Contact us before placing an order.