We appreciate your interest in Freyr’s Webinar Series. The webinar on, “EU MDR compliance of Medical Devices” is scheduled on October 7, 2020, 10:00 AM EST/EDT | 3:00 PM BST | 7:30 PM IST.
What Is It All About?
As you may know, medical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In addition, the EU MDR transition deadline is fast approaching as it will be in effect from May 26, 2021. With new regulations set up such as, General Safety and Performance Requirements (GSPR), classification rules, conformity assessment procedures, Quality Management System (QMS) and clinical investigations, device manufacturers must understand and be prepared for the compliant transition to ensure successful market-entry. In this scenario, to enable manufacturers with the best of knowledge on MDR and how is it different from the existing MDD, and to make them chalk out considerable Regulatory strategies, attend Freyr's exclusive webinar on:
EU MDR compliance of Medical Devices
October 7, 2020
10:00 AM EST/EDT | 3:00 PM BST | 7:30 PM IST
Duration – 60 Minutes
Client Partner, Medical Devices
Kristen Laudicina is the Client Partner 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.
Medical Device Regulatory Affairs- US, Canada and EU
Shilpa has been working as a Regulatory Affairs professional for over 7+ years with rich experience in diversified Medical Device categories and has supported organizations ranging from small start-ups to multi-national corporations. As an experienced Regulatory professional, Shilpa’s core work involves managing strategic services for Freyr’s global Medical Device clients for their US, Canada and EU Medical Device Regulatory requirements. Shilpa has a Master’s degree in Regulatory Affairs.
During the webinar, Kristen Laudicina - Our Client Partner, will moderate the session and our in-house Regulatory expert – Shilpa Gampa, Delivery Manager, Medical Devices will elaborate on:
- The EU MDR requirements for various device classes
- Class I medical devices- what’s different from EU MDD?
- Clinical and safety requirements under EU MDR
- QMS compliance – ISO 13485:2016 and MDSAP – impact of EU MDR
- European authorized representation – additional responsibilities under EU MDR
- Notified Bodies – key considerations
With due respect to your busy schedule, we really look forward to seeing you in the webinar. Stay safe.