Session Preview: EU MDR Quality System Alignment Conference

by Nov 26, 2019Medical Device

Jon Cornell, Head of Quality at Coloplast is a featured speaker presenting at the inaugural EU MDR: Quality System Alignment Conference. This event will take place December 4-5 in Chicago, IL. Keep reading for more about Cornell, where he will lend his perspective and what participants can gain.

 

Can you please give a brief description of your job title and what that entails? 

 

My current role is the Head of Quality responsible for our US headquarters located in Minneapolis, MN.

 

EU MDR Quality System AlignmentCan you give a quick summary of your sessions, “Case Study: Updating Quality Manuals under EU MDR Implementation” and “Accurate Formatting of Periodic Safety Update Reports”?

 

Updating Quality Manuals under EU MDR Implementation – Our project plan team assessed the existing QMS compared to the new MDR regulations, updated our SOP’s, WI’s, forms, templates, IT systems, and then revised the Quality Manual. This was a very cross-functional effort that took a lot of planning and CR work to implement.

 

Accurate Formatting of Periodic Safety Update Reports – We based our initial template on the pharma industry, and revised the format and content of the current PSUR template based upon the recent guidance released.

 

 

Do you have any actionable tips for quality teams regarding setting reporting standards? 

 

  • Develop a template and procedure
  • Obtain cross-functional alignment of product schedule for PMS Plans
  • Review strategy with Notified Body to ensure alignment

 

What are 1-3 main takeaways you hope attendees learn from your presentations?

 

  • Clear vision and ambitious strategic plan with milestones to ensure success
  • Take a risk based approach to help prioritize
  • Get started now

 

Don’t miss this session and many others covering quality management procedures under the EU MDR at the EU MDR: Quality System Alignment Conference.

Natalie Zunker is a Content Marketing Associate for Q1 Productions, where she is responsible for campaign planning, content development and executing marketing projects for the life sciences, pharmaceutical and food and beverage industries.

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