Are you interested in selling your medical device in the European Union, but are not sure how to go about meeting the Medical Device Directives' quality standards? You will be pleased to know that EN ISO 13485 meets most of the QMS requirements outlined in the Directives, which is why many medical device companies choose to implement it before entering the European medical device market.
In this video we will learn more about the background of this global Quality Management System standard, and the steps you can take to obtain ISO 13485 certification in Europe, as well as how the standard can support QMS requirements around the world.
Major sections in this video:
- Overview of EN ISO 13485:2012 - [1:10]
- Key Players - [4:00]
- QMS Analysis and Planning - [7:01]
- Document Development and Implementation - [10:23]
- ISO Certification Audit - [18:19]
- Maintenance of Your QMS - [24:01]
- FAQ - [25:42]
Information in this video accurate as of November 10, 2015.
Europe CE Marking Regulatory Process for Medical Devices
Free process chart outlines the process to obtain a CE Mark.
In Depth Video: Europe medical device approval and compliance
[Runtime: 21 min]
Free video. The approval process in Europe is complex, but in this video we break it down into understandable steps and explain each one. This video is made up of seven smaller videos, and you may skip to another part at any time.
European Technical Files For CE Marking Of Medical Devices
This free white paper discusses the purpose of a technical file, the data and documentation included, formatting, and other topics.