Medical Device Network Group Denmark

Medical Device Network Group: MDR & IVDR

Change management and project management: Get a holistic overview to assess and implement MDR & IVDR

February 28, 8:30 - 10:30
Epista Life Science HQ - Slotsmarken 17, 2970 Hørsholm, Denmark

Presentation available here: MDR & IVDR - Project Management & Change Management

The new MDR & IVDR requirements pose critical challenges for Medical Device companies. As a Life Science professional working with Quality, you may already know that timelines to implement these requirements are critical: MDR & IVDR must be a business priority. At the moment, there is little awareness of these new requirements, their impact, or the resources needed.

Join this Medical Device Network Group to discuss your challenges together with industry peers and subject-matter-experts. We’ll meet over coffee & croissants to discuss the most important challenges of the day, and gain valuable inspiration, insights, and operational tips.  This first meeting of the Network Group is focused on MDR & IVDR.

At this first meeting, Hanne Harbo Hansen, Principal Consultant at Epista Life Science, will share her industry expertise, followed by Q&A and discussion. Hanne will discuss an often-overlooked aspect of an MDR or IVDR project -  change management and project management. She'll explore how you can get a holistic overview to assess and implement these new requirements.

With little awareness of the impact that new regulatory requirements will have on the company, Quality professionals are in an important position. Time is of the essence, and it is up to you to convey how critical it is to upper management. You must approach management, get resources, make timelines, and assess the impact within the company, then start up and structure the project. Hanne will explore these topics, using a case example from a Swedish Medical Device company. If you’re a QA or SME that must request resources from your management chain and want to find the best way to structure a project to do so, you need this holistic overview to succeed.

We will discuss:

- How to approach management
- How to set up change management
- How to start up and structure the project

Register now to join your peers.


Introduction: Introduction of Medical Device Network Group
Karin Grostøl Nielsen, Principal Consultant, Epista Life Science

Change management and project management for an MDR and IVDR project: How to get a holistic overview to assess and implement these new requirements
Hanne Harbo Hansen, Principal Consultant, Epista Life Science

Group Discussion

Wrap up and discussion of topic for next meeting
Karin Grostøl Nielsen, Principal Consultant, Epista Life Science

What is the Medical Device Network Group all about?

Those of us in the Life Science industry know that sharing insight, tips, tools, and experience is invaluable to the success of a project and ultimately the growth of a company. This network group is a space to meet with peers over coffee & croissants, and gain valuable insights, inspiration, and operational tips for improving the quality and outcome of your organization's compliance efforts. This is the first meeting of the new group.  

Note: This is an open invitation for industry practitioners. If you fall into this category, please share with colleagues and other relevant people in your network. (Remember registration). This event is not open to consultants or vendors.

Read More: Expert Article Series on IVDRWe dig deeper into some of the key implications of the IVDR in this 5-part series.

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