Webinars
Live Webinar
New Approach of Toxicological Risk assessment of Leachables & Extractables - Experiences, Challenges, & Case studies
ENGLISH 8th February, 2024 | 3-4pm CET
GERMAN 8th February, 2024 |10-11am CET
The revised ISO guideline 10993-17 was published in the end of 2023 implementing new concepts for the toxicological risk assessment of medical device constituents. Within this webinar, details on the changes and new approaches will be provided. Furthermore, focus will be drawn to recent experiences, general challenges and pitfalls as well as case studies in the context of the toxicological evaluation of leachable and extractable substances.
Speaker: Marcel Dörkes, Deputy Head of Consulting at Eurofins Medical Device Consulting Europe
ENGLISH Register here
GERMAN Register here
Live Webinar
Navigating through the jungle of ISO 11607 - Achieving a packaging validation strategy
15th February, 2024 | 11am EST | 8am PST | 3pm CET
Speakers: Pascal Ayasse, Head of the Validation and Sterilisation department and Lisa Heilemann, Head of Validation at Eurofins Medical Device Testing Europe
Register here
Live Webinar
Handling Cytotoxicity Failure: Why it is not the end?
19th February, 2024 | 11am EST | 8am PST | 3pm CET
Cytotoxicity is one of the most common assays performed as a part of medical device biocompatibility assessments. It is also very sensitive, and as a result many medical device companies find themselves having to handle positive cytotoxicity results with their products. These results need to be addressed, though they should be treated as a question that needs to be answered rather than a definitive flaw in the product. It may indeed be possible to demonstrate that the device in question is safe in its intended use despite the cytotoxicity results. Join us as we explore how to approach these cases and, when possible, make a safety case for a device despite positive cytotoxicity results.
Speakers: Paolo Pescio, Technical Referent at Eurofins Medical Device Testing and Geoffrey Moddie, Director of Biocompatibility at Eurofins Medical Device Testing
Register here
Live Webinar
Ophthalmic Delivery Systems – Drug and Device Considerations
14th March, 2024 | 11am EST | 8am PST | 3pm CET
In this webinar, Rick Camp, President, Eurofins BioPharma Product Testing ENCO provides expert insights on ophthalmic drugs and devices. From ophthalmic drug relevance and development pathways to the variety of choices for delivery route, this webinar will provide additional insights on common questions such as:
- The increasing importance of eye health
- Advantages and challenges of Ophthalmic Delivery
- Differences in the development pathway for ophthalmic drugs and devices
- Regulation as a drug or device
- The unique challenges presented by combination products
Speakers: Rick Camp, President at Eurofins BioPharma Product Testing ENCO
Register here
Live Webinar
Chemical Characterisation: how to perform an E&L study for drug-like Medical Devices?
22nd February, 2024 | 11am EST | 8am PST | 3pm CET
Speakers: Daniele Lioi, Senior Consultant at Eurofins Medical Device Consulting Europe and Enrico Franzoni, Chemical Laboratory Manager at Eurofins Medical Device Testing Europe
Register here
Live Webinar
Stability Studies of Medical Devices
29th February, 2024 | 11am EST | 8am PST | 3pm CET
Speakers: Sylvain Darondel, Business Unit Manager BioPharma Stability Storage at Eurofins BioPharma Product Testing Europe and Vincent Rietsch, Business Unit Manager Eurofins Medical Device Testing Europe
Register here
Live Webinar
Strategic Implementation of ISO 10993-17: Reusable Medical Devices
7th March, 2024 | 11am EST | 8am PST | 3pm CET
Speakers: Raina Sota, Medical Devices and Toxicology Team Coordinator at Eurofins Medical Device Testing Europe and Paolo Pescio, Senior Scientific Director and ERT at Eurofins Medical Device Consulting Europe
Register here
Live Webinar
The Post Market Surveillance: Regulatory requirements and practical implications
14th March, 2024 | 11am EST | 8am PST | 3pm CET
Speakers: Daniele Lioi, Senior Consultant at Eurofins Medical Device Consulting Europe and Maria Rosaria Sollo, Medical Device Senior Consultant at Eurofins Medical Device Consulting Europe
Register here
Live Webinar
CE/MDR versus FDA submission : Biocompatibility requirements. Differences, Challenges & pitfalls
ENGLISH 21st March, 2024 | 3-4pm CET
GERMAN 21st March, 2024 | 10-11am CET
Speaker: Oliver Berberich, Consultant at Eurofins Medical Device Consulting Europe
ENGLISH - Register here
GERMAN - Register here
Take a look through our extensive list of On-Demand webinars to find the information you need.