Join PCG Clinical Services and QAdvis for a half-day Medical Device seminar followed by a lunch mingle at Kista Entré on June 1st. The seminar will outline the new Medical Device Regulations (MDR 2017/745) and in-vitro Diagnostic Regulations (IVDR 2017/746) that will come into effect over the next two to four years. PCG and QAdvis will present strategies and opportunities to navigate through these new requirements. The seminar will explore clinical evaluation and clinical performance evaluation regulations as well as clinical investigation techniques for 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. Since our event is fully booked, you can register for the waiting list, if a spot opens up, be the first to get it.
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
10:15 – 11:00 PCG
• Clinical investigations/ clinical performance
• Importance of Biometrics
• The PCG solution
11:00-11.10 (PCG & QAdvis)
Summary, PCG & QAdvis advantage
11:10-11.30 Q&A (All)
We look forward to seeing you here!
Cecilia Emanuelsson, Principal Consultant
Cecilia has extensive experience from the medical device industry together with a strong academic record – a combination well suited for covering all aspects of clinical evaluation / clinical performance evaluation. Cecilia holds a PhD from the Medical faculty at Uppsala university.
Robert Ginsberg, Principal Consultant and Chairman of the Board
Robert specializes in software regulatory issues relating to medical devices and modern software engineering methods. He has through the years worked with resolving potential issues with aligning the regulations and iterative software development methods. Robert has a physics/engineering background, and has implemented modern software engineering methods at several medical device companies, large as small. He has the last 15 years been an active member of international standardization committee, ISO and IEC. Robert is Chairman of board at QAdvis and is currently working as a consultant helping medical device companies finding cost effective implementation of regulations for medical device software. Robert has a MSc in Engineering Physics from Uppsala University.
Maria Axetun, Project Management Viedoc Trials, PCG Clinical Services
Maria Axetun joined PCG Clinical Services in 2016 and her current position is Project Manager in Viedoc Trials. She has almost ten years of experience within all phases of clinical trials and clinical investigations. Her expertise is eCRF design/setup and EDC administration, but she has also great experience in process development, data validation, programming, coding, clean file and quality control. Maria contributes with input to the design of the eCRF to get the best value of the data collected.
Daniel Seisdedos, Clinical Project Manager (CPM II), PCG Clinical Services
Daniel Seisdedos, Clinical Project Manager and PCG Clinical Services’ Safety Team Lead. Daniel’s experience covers all phases of clinical investigations and trials from first in man to post marketing and includes many different roles and functions like Monitoring & Project Management.
Antonio Mastroianni, Business Developer at PCG Clinical Services
Antonio has 20 years of multi-sector experience in government, non-profit, standard-setting bodies, and for-profit organizations. Over the course of working with various organizations across the US and Europe Antonio has specialized in IT/Telecom management consulting and Healthcare. His primary focus today with PCG Clinical Service is in partnership management, business development, and transformation.