September 21, 2019 - September 21, 2019
/ USA - Philadelphia, United States
Date: 21st of September - 24th of September
Event: Raps Regulatory Convergence
Location: Philadelphia Convention Center
Join the only conference focused exclusively on regulatory for the healthcare products industry. Find new ways to examine and solve regulatory challenges, network with the best regulatory professionals in the world and get the latest, most up-to-date industry knowledge
Our consultants from all over the world will gather to share their knowledge with you!
Gert Bos will debate on the status of implementation of the EU MDR and IVDR. Lorry Huffman will talk about how you move beyond knowing what the IVDR requirements are and how to fulfill them.
Mindy McCann starts the conference with the workshop: Demystifyng the EU MDR: from Transition to Implementation. Mindy will also give multiple sessions about the IVDR. One session will focus on the QMS implementation of the MDR and IVDR. The other session will look more in to the strategy side for succesful CE certification of IVD devices.
Jasmin Hunter and Michael Yan will differentiate between China CER and EU CER during the workshop: Different logic on clinical evaluation between device under application and equivalent device. Discussing answers to difficult China CER questions.
For the full schedule or registrations, please click here! We hope we will see you there!