- Introduction and Overview of State-of-the-art (SOTA) for Medical Devices
- The Significance of State-of-the-art (SOTA) Throughout the Life Cycle of the Medical Device
- Ways to Establish State-of-the-art (SOTA)
- Challenges and Expectations from a Notified Body (NB)
- Collateral Benefits
- Value of having a dedicated writing Team
As a continuous practice, Freyr is destined to organize more on-demand webinar sessions related to Regulatory aspects of Life Sciences. We presume that you would like to be a part of it. Hope to see you in our next webinar.
Kristen Laudicina is the Vice President of Strategic Account for Freyr’s Medical Devices Center of Excellence (CoE). She currently oversees the North and South American Regions and supports Freyr’s Medical Device CoE team. Kristen has 12+ years of experience within Life Sciences, from Preclinical through Commercial Manufacturing, and understands the client’s needs from both a sponsor and service provider perspective.
As a subject matter expert in medical writing and with more than eight (08) years of experience in Medical Devices, Priya Ray Chaudhuri has successfully spearheaded project deliveries for a range of clients, including prominent global IVDR and MDV market leaders. She is passionate about leveraging her expertise in delivering tailored solutions that exceed expectations.
Kristen Laudicina -
Vice President of Strategic Account, Medical Devices, Freyr
Priya Ray Chaudhuri -
Subject Matter Expert, MDV Medical Writing, Freyr