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 08:45

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 Copenhagen 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.

09:05-10:00
Incl QA
Notified Body Perspective: Assessing the key clinical investigation requirements as per MDR
Dr. med. habil. René Bombien

Internal Clinician
Medical Health Services
TÜV SÜD

10:05-10:55
Incl QA
Valid information about Benefit-Risk analysis

 

Helene Quie

CEO,
Qmed Consulting

10:55-11:05
Coffee break with fresh fruit
11:05-12:00
The role of a National Competent Authority in regards to Clinical Investigations
  • The role of a National Competent Authority in regards to Clinical Investigations
  • Changed requirements to Clinical Investigations in the MDR
  • Coordinated application procedure at DKMA and The National Committee on Health Research Ethics
  • The Danish Medicines Agency’s Data Analytics Center (DAC)
Jeppe Larsen

Section Manager, Development of Medical Devices
Danish Medicines Agency

12:10-13:30
Lunch Symposium – Human Factors & Usability

Sponsored by HFUX Research | Medical Human Factors | Speech by Heidi Mehrzad, Founder
Human Factors and Usability (Engineering) for Medical Device and Combination Product Development via HFUX Research’s unique approach and HF strategy development.

Heidi Mehrzad

Founder,
HFUX Research

13:30-14:20
Notified Body Perspective: The implementation of clinical investigation requirements and PMCF to ensure compliance


Dr. med. habil. René Bombien

Internal Clinician
Medical Health Services
TÜV SÜD Denmark

14:20-14:45
Afternoon break with organic coffee and tea served with homemade cake
14:45-15:25
The Business Case for a Circular MedTech Sector
Frederik van Deurs

CEO,
Green Innovation Group

15:35-16:15
General Data Protection Regulation
Marlene Winther Plas

Partner, Head of IPT, Denmark,
DLA Piper

16:15-17:00
Networking and 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)