Join the Event as per Your Time Zone

AMR 

8:30 EDT | 20:30 CST | 9:30 BRT

EU 

14:30 CET | 13:30 BST

ROW

18:00 IST

What is it all about?

Key discussion points include:

  • EU AI Act and its relevance for SaMD
  • Risk-based classification and required documentation
  • Conformity assessment and regulatory strategy
  • Software-first certification approach by Scarlet
  • Actionable steps for proactive compliance

Freyr continues to host focused fireside chats on regulatory trends in life sciences. We look forward to welcoming you to our upcoming sessions.


Shilpa Gampa

Head- Medical Devices Delivery & Practice, Freyr

Shilpa Gampa is a Regulatory affairs strategist with expertise in FDA submissions, SaMD (Software as a Medical Device) Regulatory compliance, and C-level executive consultation for developing go-to-market strategies. She is acting as the regional delivery head for America’s clients at Freyr in her primary role for global market submissions, with a focus on innovations and Regulatory strategies for medical devices and SaMD.


Dr Camille Petri

Clinical Evidence, AI & Regulatory Specialist, Scarlet

Dr Camille Petri is a Clinical Evidence, AI & Regulatory Specialist at Scarlet. He has extensive expertise in the development, evaluation, and integration of AI & ML into healthcare and medical devices. He holds master’s degrees in Applied Mathematics, Public Health, and Artificial Intelligence, as well as an MD with a specialisation in Public Health. Dr Petri’s work bridges the technical and clinical aspects of healthcare, covering regulatory submissions of AI medical devices, clinical evidence evaluation, and the analysis of AI models. His unique combination of medical, public health, and AI expertise makes him a leading voice in the future of AI-driven healthcare, particularly in the context of upcoming regulations such as the EU AI Act.