We are proud to invite you for the Medtech Summit Dublin Conference to take place in Clayton Hotel Burlington Road – Dublin, Ireland, 20-24 June.
Our experts Ank Reumer & Thor Rollins, will deliver each a presentation at this event.
- June 23, at 10:10 am CET, presentation of Ank Reumer – Senior Study Director
When drug meets device…
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility between the components can present a danger to the patient, but how can one demonstrate the fit between a medicinal product and a device?
Using specific case studies, this talk will present the challenges that Nelson Labs has overcome in drug – device compatibility studies from a practical, analytical and regulatory point of view.
- June 23, at 11:45 am CET, presentation of Thor Rollins-BS, RM (NRCM), Toxicology and E&L Expert
How to win the game: Evaluating the biocompatibility of reusable medical devices during their whole life cycle
In the past, the focus for reusable devices has been on validating the reprocessing efficacy with regards to infection control. Recently however, and especially with the advent of the new era of MDR, the focus has expanded to include the aspect of biocompatibility, e.g. how the numerous reprocessing cycles could impact the device and whether it continues to be safe for the patient throughout its life-cycle. It is also stated in ISO 10993-1.
The theory sounds simple, but in reality, it poses extra challenges for reusable devices as they are reused and reprocessed over and over again. With that, questions, including what is happing to the materials over the lifetime of the reusable devices as these materials are attacked with detergents, disinfectants and are exposed to high temperatures, need to be answered and explored.
Find more information about this event at: https://informaconnect.com/medtech-summit/