ABOUT THE CONFERENCE
We are pleased to welcome you to the Biocompatibility testing in Medical Devices Online Conference that will take place online on the 24th-25th of September, 2020 at 9:00 CET on BigMarker.
Biocompatibility testing in Medical Devices Online Conference will give you the unique opportunity to discuss the most pressing issues and meet the representatives of the biggest companies and leaders from Biocompatibility and Medical Device Industries
Biocompatibility testing in Medical Devices Online Conference is a great platform for learning, exchanging opinions, and expanding one’s network enabled by live presentations followed by dynamic questions & answers sessions as well as panel discussions and workshops with keynote speakers.
Key points
- Biocompatibility testing
- New ISO 10993 standards
- Medical device classification
- Global harmonization of medical devices
- Material acceptance by 10993-4
- Cytotoxicity in vitro
- Immunological toxicity
- Changes in MDR
- In vitro & in vivo testing
- Role of ISO 14971 & ISO 13485 in medical devices
2-DAY ONLINE CONFERENCE INCLUDES
- 7+ different topics
- panel discussion
- networking with business professionals and industry experts
- additional materials
If you would like to participate, kindly book your spot. The seats are limited.
Broadcast Link will be provided via email post registration.
9:00 – 9:10 CET
Welcome and opening remarks from the moderator
9:10 – 9:20 CET
SPEED NETWORKING
9:20 – 9:55 CET
Current Understanding of Genetic Toxicology Testing (ISO 01993, Parts 3 & 33) of Medical Devices + Q&A
9:55 – 10:25 CET
Setting Up an Appropriate Test Program Relevant for the Intended Use + Q&A
10:25 – 10:35 CET
COFFEE BREAK
10:35 – 11:10 CET
Regulatory Perspective in Global Harmonization of Medical Devices + Q&A
11:10 – 11:45 CET
Changes in MDR: Challenges for Industry + Q&A
11:45 – 11:55 CET
COFFEE BREAK
11:55 – 12:30 CET
The Inactivation of Xenogeneic Molecules is Mandatory to Produce the Next Generation of Animal-derived Implantable Medical Devices + Q&A
12:30 – 13:05 CET
In Vitro Alternatives for Assesment of Skin Irritation & Skin Sensitization Potential of Chemicals in Medical Devices + Q&A
13:05 – 14:00 CET
LUNCH BREAK
14:00 – 14:35 CET
Biocompatibility from a Notified Body Perspective + Q&A
14:35 – 15:05 CET
PANEL DISCUSSION: Future Trends & Open Problems in Biocompatibility Testing in Medical Devices
15:05 – 15:15 CET
CLOSING SESSION REMARKS
9:00 – 9:10 CET
Welcome and opening remarks from the moderator
9:10 – 9:45 CET
The Importance of Extractables & Leachables Testing + Q&A
9:45 – 10:20 CET
The Challenges of Performing the New ISO 10993-18 Chemical Characterisation + Q&A
10:20 – 10:30 CET
COFFEE BREAK
10:30 – 11:05 CET
Harmonization of Medical Devices in Middle East Versus the Global Standards + Q&A
11:05 – 11:35 CET
Linking ISO10993-18 & ISO10993-17 from a Risk-based Perspective + Q&A
11:35 – 12:35 CET
LUNCH BREAK
12:35 – 13:10 CET
Exploring the Challenges in Medical Device Classification + Q&A
13:10 – 13:45 CET
Application of ISO 13485 in Biocompatibility Testing + Q&A
13:45 – 13:55 CET
CLOSING SESSION REMARKS
SPEAKERS
Lea Atallah
Quality & RA Manager - MENA
Zimmer Biomet
Jorge Figueira
QA manager
Pasanthe Healthcare
Sonja van der Meer
Senior Consultant
QSERVEGROUP
Nuno Félix
Quality Director
Sterisets International B.V.
Andrew Feilden
E&L European Strategic Director
Hall Analytical
Ira Sankhayan
Head of Quality & Regulatory Assurance
Otivio
Alessandro Gandaglia
CEO
Biocompatibility Innovation Srl
Rose-Marie Jenvert
Project Manager
Senza Gen
Dr. Tino Otte
Head of Sales & Consulting, Specialist Extractables & Leachables
Intertek
Annelies Vertommen
Scientific Improvement Manager
Nelson Labs
Dr. Kumaravel
Head of Toxicology and Risk Assessment
GLR Laboratory
Viktorija Galinyte
Medical Device Specialist
NEOX Clinical Research Organization
Christina Reufsteck
TÜV SÜD
