In May 2021 the Medical Device Regulation (MDR) came into effect and the U.S. Food and Drug Administration (FDA) published the updated guidance for biocompatibility assessment of medical devices in September 2023. In this webinar, we will explore the essential aspects of biocompatibility assessment and especially the differences to meet regulatory compliance in Europe and for the US FDA. Our speaker will provide valuable insights and practical guidance to help you ensure that your medical devices meet the necessary biocompatibility standards for market approval.
CE/MDR versus FDA submission : Biocompatibility requirements. Differences, Challenges & pitfalls
To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.
DATE: March 21, 2024 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://attendee.gotowebinar.com/register/8945271897940766303
ATTENDEES CAPACITY: 500 delegates
The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.
Speaker
Oliver has an academic background in Tissue Engineering and holds a PhD degree in molecular biology. He gained an advanced toxicological expertise by further training e.g., participation in the graduate program for European Registered Toxicologist. Oliver has been working in the field of evaluating the biological safety of medical devices since June 2019. His expertise includes the biological safety assessment of medical devices and related toxicological issues including strategy planning, chemical characterization procedures and associated regulatory requirements.
To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.
DATE: March 21, 2024 | 10.00 AM - 11.00 AM CET
OFFICIAL LANGUAGE: German
SUBMISSION LINK: https://attendee.gotowebinar.com/register/5564172487475019352
ATTENDEES CAPACITY: 500 delegates
The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.