Call for information: +45 51 90 86 44 welcome@medicsummit.org

Summit Programme

NEW DATE: September 15th, 2021

This 1st summit in Copenhagen at the Odd Fellow Palace will give the attendees a full day of conference with industry experts, Notified Body, lunch symposium and networking.

Summit talks – Time table.
September 15th 2021, starting at 08:30

You will find the preliminary programme here below. We make reservations for any changes in the programme.

08:30 – 09:00
Coffee and registration

Arrive in time at Bredgade 28, 1260 København and register for badge/accreditation.
Enjoy a light breakfast buffet with warm croissants and fresh fruit. Two kinds of organic juice and organic coffee and tea.

09:00-10:00
Incl QA
Clinical Investigation Requirements Assessing Changes according to the MDR2017/745

Susanne Gerbl-Rieger

Susanne Gerbl-Rieger

Director of Clinical Audit,
TÜV SÜD

10:05-11:00
Incl QA
Maximizing study outcome data for your medical device to successfully entering the market

Art Pilmeyer

 

Art Pilmeyer

Clinical Leader at EDP Solutions,
Phillips Medical Systems

11:00-11:15
Coffee break with fresh fruit
11:15-11:45
Using Real World Data in Clinical Research
  • The role of a National Competent Authority in regards to Clinical Investigations
  • Changed requirements to Clinical Investigations in the MDR
  • Tightened requirements to claimed equivalence
  • Use of historical / Real World Data in Clinical Investigations
  • Coordinated application procedure at DKMA and The National Committee on Health Research Ethics
  • The Danish Medicines Agency’s Data Analytics Center (DAC)
Thomas Wejs Møller

Section Manager, Medical Devices
Danish Medicines Agency

12:30-13:15
Lunch Symposium (with seasonal fish, meat and salad included beverages)

Sponsored by HFUX Research | Speach by Heidi Mehrzad, Founder
HFUX Research is a medical human factors and usability consultancy, specialized in medical device and combination product research, design, and development. Founded in 2017, their mission is to empower companies around the globe, from medical device and pharmaceutical startup to Fortune 500 leaders, to realize their human factors vision and usability goals.

Heidi Mehrzad

Founder,
HFUX Research

13:00-14:00
Updates and changes to the ISO 14155

Speaker: Klaas Van’T Klooster

 

Klaas Van’T Klooster

Manager External Research
DePuy Synthes Companies and member of ISO/TC 194 WG4

14:05-15:00
Clinical Evaluation and investigation, according to the MDR 2017/745

Speaker: Susanne Gerbl-Rieger

Susanne Gerbl-Rieger

Director of Clinical Audits
TÜV SÜD

15:00-15:20
Afternoon break with organic coffee and tea served with homemade cake
15:20-16:15
GDPR impact on clinical investigations

Speaker: Rahel Meister

Rahel Meister

Senior Clinical Study Manager,
Smith and Nephew

16:15-16:45
End of the Medtech Summit

Special thanks to HFUX Research

for sponsoring and hosting the Lunch Symposium

Reserve Today!And access a summit with high profile speakers from all over Europe and possibilities for quality networking during the day

Price DKK 6.500/ EUR 870 | (incl. VAT)