ISO 13485 resources and downloads.

Download our training course listing and check availability of the courses relevant to your industry and development needs. The listing includes all classroom, eLearning, virtual and in-house options.

Find out about the steps that Penlon took before pursuing ISO 13485:2016 certification, key learnings from their transition process and tips for organisations looking to change Certification Body.

More and more medical device manufacturers require suppliers and service providers to be certified to ISO 13485 as a pre-requisite for doing business. Learn more about how to achieve compliance.

LR’s medical device technical experts answer frequently asked questions to support manufacturers with the transition and address the changes that the ISO 13485:2016 revision has introduced.

ISO 13485 certification is one of the best ways to demonstrate compliance with the various laws and regulations active in the medical devices industry. This overview guide is intended as a starting point for organisations considering to get their management system certified.

Experts from Lloyd's Register answer some of the most frequent questions about implementing ISO 13485 and maintaining an effective management system.

This gap analysis focuses on how your medical management system has addressed or plans to address the ISO 13485 requirements.