Whitepapers and Brochures

Are you a self-certified IVD manufacturer?

Under the existing IVDD, approximately 80% of IVD manufacturers are self-certified and do not require Notified Body involvement. The new IVDR comes with new classification rules which will in the near future require about 80% of IVD manufacturers to require some form of Notified Body involvement, a four-fold increment from before.

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.

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.

ISO 13485:2016 - Understanding Risk Management Implications

In this 20 minute webcast, Susan Mecca, Senior Technical Manager, Medical Devices - LRQA Americas, will provide practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016, particularly those around Risk Management and the Interconnection with other Regulatory Requirements to the corresponding Medical Device Directives (MDD) and In Vitro Diagnostic Medical Devices (IVDD).

ISO 13485:2016 – Wondering where to start?

The revised standard for medical devices, ISO 13485:2016 and the European Standard version, EN ISO 13485:2016, were published earlier this year allowing a three-year transition period that will apply to all existing certificates.