Stability studies for medical devices are commonly carried out by manufacturers while the regulatory and normative framework is not always straightforward. The objective of this webinar is to provide general recommendations for the implementation of a study design according to the context. Furthermore, recent experiences, challenges and pitfalls will be shared and discussed.
Stability studies of medical devices
FREE ONLINE WEBINAR: 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: Fabruary 29 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://attendee.gotowebinar.com/register/7597794009821459039
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.
Speakers
Dr. Vincent Rietsch is Business Unit Manager of Eurofins Medical Device Testing France, with almost 10 years of experience in the field of medical devices. After his PhD in chemistry, he has developed the Medical Device field at Eurofins BPT France by creating a dedicated structure for testing and consultancy. His expertise focuses on equipment qualification and method validation for chemical and packaging testing, along with a comprehensive knowledge on ISO 10993 series. Consultancy on Biological evaluation and RA/QA are also under his scope, besides the QMS implementation under ISO 13485.
Sylvain Darondel, an engineer by training, participated in the creation in 2001 and in the development of storage and logistics activities under GMP conditions for Eurofins BioPharma Product Testing. He has developed expertise in the fields of storage in standard conditions (ICH, MDR) and specific conditions (cycling, cold) and logistics in controlled conditions for health products.