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.
Clinical Investigation Requirements Assessing Changes according to the MDR2017/745
Director of Clinical Audit,
Maximizing study outcome data for your medical device to successfully entering the market
Clinical Leader at EDP Solutions,
Phillips Medical Systems
Coffee break with fresh fruit
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
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.
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
Clinical Evaluation and investigation, according to the MDR 2017/745
Speaker: Susanne Gerbl-Rieger
Director of Clinical Audits
Afternoon break with organic coffee and tea served with homemade cake
GDPR impact on clinical investigations
Speaker: Rahel Meister
Senior Clinical Study Manager,
Smith and Nephew
End of the Medtech Summit
Special thanks to HFUX Research
for sponsoring and hosting the Lunch Symposium