ISO 13485 help and guidance

LRQA has produced a variety of useful resources about the progress and requirements of ISO 13485.

Implementing ISO 13485:2016

This on-demand webinar covers some key learnings, main areas of focus, tips for the transition process and an overview of how to maintain an effective management system in accordance with ISO 13485:2016.

Looking for answers?

Experts from LR answer some of the most frequent questions around ISO 13485:2016 to support manufacturers with implementing and maintaining an effective management system.

Penlon Client Case Study

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

ISO 13485:2016 Interview

An interview with John Howlett, LRQA Medical Devices Technical Manager, answering some of the most common questions on ISO 13485

ISO 13485 Starters’ Guide

ISO 13485:2016 Starters’ Guide to Transition is intended as a starting point for medical device manufacturers who are considering what steps to take towards a smooth transition to the new and revised standard.

13485 datasheet

Guide to ISO 13485:2016

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

ISO 13485:2016 Infographic

ISO 13485:2016 is published. Learn what’s new, the main areas of focus and what you should be doing next.

Susan Mecca Interview Download ISO 13485

The new ISO 13485:2016 - An interview with Susan Mecca

In this two-part series interview Susan shares her thoughts on the new ISO 13485:2016 medical Quality Management System (QMS) standard, and how it impacts manufacturers.

ISO 13485:2016 in 7 steps

By following these simple steps, LRQA can help you get certified to ISO 13485:2016 the international standard for medical device manufacturers and suppliers.

Oceanz ISO 13485 case study

Find out how ISO 13485 certification paves way for Oceanz to apply life-saving medical 3D printing technology on a global scale.

ISO 13485:2016 FAQs

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 13485:2016 Webinar

This on-demand webinar will help you understand & implement the main changes within the revised standard