Biomedical Consortium Current Events

Presented by

RQ TeamSt. Cloud State University Plymouth

Know the essential EU MDR requirements.

Now that the EU MDR changes are in force and we are quickly moving toward the date of application, you need to be working with your notified body to plan and implement transition activities. This includes those potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. Come learn what to do.

The time to plan and act on these changes is now.

Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs).

This webinar will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but our experts will be able to help you navigate the process.

 What’s covered?

In addition to the background/history of EU MDR, the stacking effect for notified bodies, and proposed solution, the session will cover the key EU MDR changes, including:

  • Classification changes
  • Increased clinical evidence
  • Expert group consultations for higher risk devices
  • Increased scrutiny of technical documentation
  • Supply chain controls
  • Emphasis on control of reprocessing and reuse of devices
  • “Responsible Person”
  • Common specifications
  • Trending and PMS
  • State of the art assessments
  • Eudamed database
  • Unique Device Identification (UDI)
  • General safety and performance requirements
  • Unannounced audits
  • What to do: recommended next steps

Key takeaways

  • Learn the essential EU MDR requirements
  • Know how it might impact my company
  • Understand immediate actions and potential next steps
  • Practical tips and guidance for implementation
  • Valuable insight from experienced industry leaders

When: Tuesday, November 14, 2017 (8:00 am – noon) – (Check-In/Continental Breakfast begins at 7:30 AM)

Where:  St. Cloud State Graduate Center – Plymouth

               9750 Rockford Road, Plymouth, MN 55442‎

Who Should Attend: Engineers, Management, and other Employees responsible for Quality, Reliability, Regulatory, Production, and Development at Medical Device Manufacturers.  Suppliers, Contract Manufacturers, and persons interested in the Biomedical Industry will also find this workshop valuable.

Cost:  -Minnesotregister buttona ASQ Member – $125

-ASQ Enterprise Member- $125

-Non-Member – $150 

Continental Breakfast is included.

Certificates of Completion: Issued on workshop completion for 0.3 ASQ RUs or 0.3 CEUs.

.Instructor Bio: Mark Swanson (CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group; a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. In addition to this, Mark is currently the Director of the Medical Technology Quality Graduate program at St. Cloud State University’s Twin Cities Graduate Center in Maple Grove, Minnesota. This innovative program was started in 2012 to provide quality professionals with graduate level learning in the application of quality management principles, particularly for those in the key Minnesota industry of medical devices. Mark has spent the last 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 e>ectively integrate these various international standards and other regulations into a single quality management system.