Dr. Matthias Fink is board certified orthopedic and trauma surgeon with over 17 years of experience in orthopedic, trauma and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. He has expert knowledge in the field of orthopedic implants and cardiac devices. Dr. Fink has also worked as a Clinical Reviewer for the Clinical Centre of Excellence for TÜV SÜD Product Service in Germany before joining TÜV SÜD America in 2017. He is the Global Team Leader for the Ortho, Trauma and Dentistry Team within the Clinical Centre of Excellence of TÜV SÜD and the Team Manager of the Clinical Focus Team in North America. He has been a presenter at national and international conferences on the clinical requirements and the implementation of the EU MDR. Dr. Fink is also an external trainer on clinical and post-market aspects under the MDR for TÜV SÜD America. During his clinical career he has been an investigator and co-investigator in national and international clinical studies for medical devices and Phase III and IV clinical trials for pharmaceuticals.
Dr. Pratibha Mishra is an Associate Manager, Medical Device Services, at Celegence leading a team of qualified medical writers. She has a Master’s degree in Oral Medicine and Maxillofacial Radiology and has written and reviewed regulatory documentation for Medical Devices covering a wide range of therapeutic areas – dentistry, ophthalmology, thoracopulmonology, gastroenterology, endoscopy, urology and dialysis, general surgery, electrosurgery, female reproductive health, cosmetic surgery, diagnostic and interventional radiology, and cardiology. Dr. Mishra’s team has successfully conducted clinical evaluations for complex devices including Software as Medical Device (SaMD) and Drug-Device Combination Products. She is experienced in developing MDR compliant templates for CER, CEP, PMCF Plan, and PMCF Report, and drafting responses to Notified Body observations on clinical evaluation.
The webinar will detail and cover the following items:
- Overview of CE requirements for EU MDR Compliance
- Updates on regulations and guidance documents
- Combination Products
- Software as a Medical Device (SaMD)
- Legacy Devices
- Strategy and approach to consider for specific product types
- Q/A with panelists from TUV SUD, industry manufacturer, and Celegence experts