Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: March 28th, where we'll discuss the Medical Device Single Audit Program (MDSAP).

Risked Based Approac to QMS Implementation New ISO 1348 Standard


Please join us for a free R&Q Intelligence Series webinar:
A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015.

The session will be held on Thursday, February 28th from 1:00pm - 2:00pm EST and be presented by R&Q Director of Minnesota Operations / Principal Consultant - and ISO Technical Committee 210 (TC210) and Working Group 1 (WG1) member - Mark Swanson. Cost of the webinar: free.

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This webinar presented by Regulatory and Quality Solutions outlines how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485.

In this session, we will establish a basic understanding of the application of the risk-based approach in your QMS process, the evidence that will show this implementation to auditors and how these are implemented in your update to your QMS.


To maintain the ability to market devices, medical device organizations need to update their Quality Management Systems (QMS) to ISO 13485:2016, and they must have an understanding of applying a risk-based approach throughout the processes of their QMS.

If you haven’t started working on this transition, this will give you key aspect of the change and practical steps to take for updating your QMS.


Tuesday, February 28 
1:00 - 2:00pm EST


The session will be presented by R&Q Director of Minnesota Operations / Principal Consultant - and ISO Technical Committee 210 (TC210) and Working Group 1 (WG1) member - Mark Swanson.

Mark Swanson New ISO 13485 Standard ExpertMark (CMQ/OE, CQE, CBA) has spent more than four years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016 and has also participated with ISO TC176, WG24 on ISO 9001:2015. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single quality management system.

And remember, the recording and webinar slides will be made available to anyone who signs up!

Register Now


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