Whitepapers and Brochures

ISO 13485:2016 - Gap Analysis

LRQA’s Gap Analysis assessment examines and reports on your management systems’ readiness for transition. It focuses on how your management system has addressed, or plans to address, the changes introduced through the publication in ISO 13485:2016.

How to launch your Medical Device

LRQA’s guide to the MDR Conformity Assessment Procedures will help you understand the different routes to compliance, and which route applies to your medical device.

How to Launch Your In Vitro Diagnostic Device

Then, based on the classification of the IVD, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.