(EU) 2017/745 New Medical Device Regulation (MDR) Support Services to Notified Bodies

Comparative Equivalence

Medaval offers a comparative-equivalence service in readiness for (EU) 2017/745 and is MEDDEV 2.7.1/rev 4 compliant now.

 

Complete Validation Studies

We offer complete validation studies. We have a panel of laboratories, taken from our Investigators Panel, that we blind pick to do the work independently.

Branding

Devices certified by Medaval can carry a Medaval Certification of accuracy, on its packaging, in its literature and in advertisements for that device

Accreditation

Medaval awards a Certificate of Accreditation to devices that have been proven to be accurate, for a particular function, according to a specified protocol.

Other Services offered by Medaval

In-House Audits

Medaval’s introduces a new service for manufacturers called ” In House Validation Audit”

Assessment Reports

Medaval’s comprehensive assessment reports on Accredited Devices are available for purchase