Medical Related Standards

Medical Standards and schemes

In-Vitro Diagnostic Directive - New EU IVDR

The In-Vitro Diagnostic (IVD) Device Regulation is approaching the final stages of the review process before becoming law and is the proposed revision to the existing IVD Directive 98/79/EC.

MDD 93/42/EEC Medical devices

We’re designated as a notified body under the medical devices directive for medical devices using the quality system conformity routes laid out in Annexes II, V and VI.

MDSAP - Medical Device Single Audit Program Certification

Recognizing that a global approach to assuring the safety of medical device manufacturing would provide tremendous benefit to the industry and the end user, the International Medical Device Regulators Forum (IMDRF) has created a harmonized approach to auditing and monitoring the manufacturing of medical devices.

Medical Devices Directive - New Regulation

As with the upcoming In-Vitro Diagnostic (IVD) Device Regulation, the proposed Medical Device Regulation (MDR) is also approaching the final stages of development before becoming law as a Regulation.