ISO 13485:2016 Resources

We have a variety of resources about ISO 13485:2016 including: datasheets, interviews, podcasts, webinars, case studies and independent research to help you to get the best from your quality management systems.

ISO 13485:2016 Whitepapers and Brochures

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.

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).

LRQA MDR and IVDR Webinars

The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC and In Vitro Diagnostic Device (IVD) Directive 98/79/EC. Both Regulations are currently in their final stage of development and are expected to be published towards the end of Q1 2017.

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.