Welcome to our Medical Device Clinical Evidence Event
Clinical evidence for CE marking of medical devices and IVD devices according to new MDR and IVDR - Requirements and possibilities!
Join PCG Clinical Services and QAdvis at this very special half-day Medical Device seminar followed by a lunch mingle in Medicon Village on March 23rd. The seminar will outline the new Medical Device Regulations (MDR 2017/745) and in-vitro Diagnostic Regulations (IVDR 2017/746) that will come in effect over the next two to four years. PCG and QAdvis will on the basis of these new regulations present strategies and possibilities to navigate through these requirements. It involves clinical evaluation and clinical performance evaluation regulations as well as clinical investigation techniques involving products both before and after CE-marking.
QAdvis is a long time trusted provider of medical device regulatory services and PCG Clinical Services is a full-service CRO committed to improving clinical investigations through our scientific expertise, progressive technology and more effective ways of working.
Presentations and Q&A are verbally held in Swedish. View our agenda and register before seats run out!
Agenda:
08:15 – 08:45
Registration and coffee
08:45 – 08.50
Welcome to the PCG & QAdvis advantage (PCG)
08:50 - 09:10 QAdvis
Intro to the MDR & IVDR news
• Key challenges
09:10 – 10:00 QAdvis
• Clinical evaluation according to MDR
• Clinical performance evaluation according to IVDR
10:00 – 10:15
Fika break
10:15 – 11:00 PCG
• Clinical investigations/ clinical performance
• Design/Viedoc
• Importance of Biometrics
• The PCG solution
11:00-11.10 (PCG & QAdvis)
Summary, PCG & QAdvis advantage
11:10-11.30 Q&A (All)
Lunch mingle
We look forward to seeing you here!
Medicon Village complex map