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 - 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).

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.