ISO 13485 help and guidance

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

ISO 13485:2016 Interview

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

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 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.

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 Infographic

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

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

LRQA’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.