Conference Day 2

8:30 AM - 9:00 AM Registration and Coffee

9:00 AM - 9:10 AM Chairman's Opening Address

9:10 AM - 10:30 AM Interactive Breakout Session : MDR- Have You Done Your Homework and Analysed Your Gaps?

Tommy Roy Røsholt, UDI Project Manager | NPI Project Manager, Oticon Micael Johansson, Founder and CEO, Nimio AB
· Short introduction to major changes/gaps
· Mapping out your real "to do list"
· Examine first hand experiences from analyses to implementation
· Consider design issues such as:
- Choosing an appropriate Notified Body
- MDD vs MDR and product portfolio management
- Handling your resource management within and without your company
- Understanding re-classifications and their implications
- Discussing economical operators requirements
- Utilising Basic UDIs – practical implementation and timelines

Tommy Roy Røsholt

UDI Project Manager | NPI Project Manager
Oticon

Micael Johansson

Founder and CEO
Nimio AB

10:30 AM - 11:00 AM Morning Coffee Break

11:00 AM - 11:40 AM Developing a Tailored Med Device Compliance and Oversight Strategy from the Perspective of a Small Company

Andreas Mueller, Senior Manager Clinical and Medical Affairs, Signus Medizintechnik
· Integrate a proactive risk based methodology
· Ensure transparency in your audit and reporting protocols
· Align your clinical trial outcomes and strategy within the regulatory frameworks
· Create a timeline for your clinical evaluations to ensure effective program monitoring

Andreas Mueller

Senior Manager Clinical and Medical Affairs
Signus Medizintechnik

11:40 AM - 12:20 PM MDR? - Hands up? or Hands on!

Matthias Binder, Senior Manager, Regulatory Affairs, CROMA-PHARMA
· Creating a time-sensitive framework to implement the MDR
· Understand what comes next – how can we decide and what are the consequences?
· Identify what the MDR means for class IIa, IIb and class III devices – how the first to be targeted are the ones that need the greatest clinical adaptation

Matthias Binder

Senior Manager, Regulatory Affairs
CROMA-PHARMA

12:20 PM - 1:20 PM Networking Lunch

1:20 PM - 2:00 PM Agile Management: Product Innovation with Streamlined Compliance

Nancy Van Schooenderwoert, President and Managing Partner, Lean-Agile Partners, Inc.
* What makes the Agile mindset tick - why both safer products and lower
overhead costs result
* How to gain alignment across disciplines, and the wider business team
* Compliance comes “for free” because it’s grown from scratch not added
on afterwards
* Although Agile started in software, its core elements work for
hardware and other disciplines
* Agile leadership creates greater employee engagement, which fuels
teamwork, discipline, and compliance

Nancy Van Schooenderwoert

President and Managing Partner
Lean-Agile Partners, Inc.

2:00 PM - 2:40 PM How to Manage Regulatory Requirements Across Your Clinical Trials

Myriam Desmet, Director Regulatory, Quality & Clinical Affairs, Diabeloop
· Understand the limitations of pre-market clinical data
· Integrate human factors and usability into design controls and the clinical trial to yield optimal trial results
· Plan your approval submission – ensuring that all stakeholders are aligned on project objectives and regulatory submission requirements

Myriam Desmet

Director Regulatory, Quality & Clinical Affairs
Diabeloop

2:40 PM - 3:10 PM Afternoon Coffee Break

3:10 PM - 3:50 PM Implementing a Robust Post Market Clinical Follow Up (PMCF) Strategy

Dorota Johansson, Clinical and Research Director, Bactiguard
· Build a portfolio of PMCF studies as a competitive assessment of your Medical Device
· Prepare a clinical evaluation report and post market plans for real time updates and analysis
· Create a loop between post market feedback, post market clinical studies and clinical evaluation

Dorota Johansson

Clinical and Research Director
Bactiguard

3:50 PM - 4:30 PM Creating a Framework for Efficient Cross Functional Medical Device Evaluations

Abdulkareem Sawwan, Regulatory Affairs Project Manager, Owen Mumford
· Map the cross-functional impact of regulatory changes
· Implement a pro-active risk management model to ensure constant compliance
· Train your team – how to communicate regulatory impact across your device development teams
· Pinpoint effectiveness of procedures and ongoing challenges through ongoing training and feedback

Abdulkareem Sawwan

Regulatory Affairs Project Manager
Owen Mumford

4:30 PM - 5:15 PM Summative Panel Discussion – An Analysis of the Ongoing Standardisation of Med Device and IVD Regulations

· Analyse the effect of standardisation on the agility and reactiveness of Medical Device or IVD trials
· Optimise the value of your UDI – creating a framework around traceability
· What is the role of a notified body and how do you put in place a collaborative structure?

5:15 PM - 5:25 PM Chairman's Closing Address and Close of Conference