Preconference Workshop: Change Management on MDR and IVDR

This preconference workshop provides both key fundamentals and lean innovative strategies to approach change management under EU MDR and IVDR. As many manufacturers look forward to implementing product and process changes, it is important to consider both impact assessment, notification and implementation from a lean perspective. While on one hand, underdoing could lead to non-compliance, overdoing change management can lead to additional complexity, time and cost.

There are no specific regulations, standards or guidance documents that address change management completely. Effective change management must consider the size and complexity of the organization in light of the applicable regulatory requirements and state-of-the art guidance. Manufacturers must rely on relevant sources to create an effective and compliant change management system.

In this workshop, several case studies and tailored strategies will be discussed to allow effective implementation and adaption of change management processes.

Preconference Workshop Agenda:

7:30 – 8:30 AM: Networking Breakfast & Welcome for Workshop Registrants

8:30 AM: All Preconference Workshops Begin

8:30 – 09:30 AM: Introductory session on the legal requirements and guidance documents in the EU – Is it possible to remain lean in implementation? (Speaker(s): Anna Spehl)

9:30 – 10:00 AM: Preparation for a legislative change and the new change management per EU MDR (Speaker(s): Poornima Bedi)

10:00 – 10:30 AM: Preparation for a legislative change and the new change management per EU MDR (Speaker(s): Glenda Marsh)

10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Registrants

11:00 – 11:45 AM: Notified body perspective: Implementation of the EU MDR/EU IVDR and the new process for managing changes over the certification cycle (Speaker(s): Tom Patten)

11:45 - 12:30 PM: Panel Discussion – Requirements vs. Lean Principles (Speaker(s): All)

12:30 – 1:30 PM: Lunch & Networking for Preconference Workshop Registrants

1:30 - 2:00 PM: Case Study - Product change under MDD/IVDD (Speaker(s): All)

2:00 – 2:30 PM: Case Study - Process change under MDD/IVDD (Speaker(s): All)

2:30 – 3:00 PM: Case Study - Product change under MDR/IVDR (Speaker(s): All)

3:00 – 3:15 PM: Refreshment Break for Preconference Workshop Registrants

03:15 - 03:45 PM: Case Study - Process change under MDR/IVDR (Speaker(s): All)

03:45 – 4:00 PM: Closing (Speaker(s): All)

4:00 PM: All Preconference Workshops Adjourn for Day