Only for employees of member companies.

The aim of the day is to see what is in the future of the clinical area for medical devices and also meet peers working with clinical evaluations, clinical investigations and post market clinical follow-up and exchange experience.

Preliminary Agenda 

08.30 – 9.00 Check in & breakfast 

09.00 – 9.05 Welcome & introduction, Pernille Trøjgaard, Coloplast  

09.05 – 10.00 Keynote: Danielle Giroud: 

• ISO 14155 update – what is new? 

• Status on ISO18968 

• PMCF – how to and challenges  

10.00 – 10.20 Coffee break  

10.20 – 10.45 PMCF-cases by Uneeg & Coloplast v/Pia Nordmand og Pernille Trøjgaard  

10.45 – 11.30 Notified Bodies perspective on PMCF-studies, Breda Kearnsey, BSI 

11.30 – 12.30 Lunch  

12.30 - 13.15 AI-talk by professor Thiusius R. Savarimuthu, The Faculty of Engineering, The Maersk Mc-Kinney Moller Institute, SDU Robotics 

13.15 – 14.00 Group discussions: How do you use AI in your daily work within clinical investigations and evaluations? 

14.00 – 14.15 Coffee break 

14.15 – 14.45 Danish Ethical Committee: Findings from workshop and future works, Mikkel Lindskov Sachs

14.45 – 15.15 DKMA News: ‘Clinical Investigation and Evaluation and Performance Study and Evaluation’ group, COMBINE and Well-Established Technologies (WET), Ugur Ermann, Danish Medicines Agency 

15.15 – 15.30 Wrap up of group discussions & conclusion of the day