Venture Center

Understanding Medical Device Regulations in the US Market

Join our awareness talk on

Understanding Medical Device Regulations in the US Market

Learn about the key insights into FDA requirements, with a focus on substantial equivalence and the 510(k) process.

Event Details:

  • Date: 29th October, 2024
  • Time: 11:00 AM to 12:00 PM
  • Mode: Online (Zoom Platform)

 

About the Speaker:

Akash Dhade (Associate Manager - Regulatory Services)

Akash works for the Regulatory Information Facilitation Center (RIFC) at Venture Center and has assisted multiple organizations in choosing regulatory pathways, creating technical documentation, and submitting documentation to the notified bodies for the European market. He was involved in creating 510(K) summary documents for different device classes. He has experience in communicating and resolving queries from the US FDA regulatory authorities. Akash has obtained the lead auditor certification for ISO 13485 QMS from the BSI Academy.

Highlights:

  • US FDA classification system and approval pathways

  • Importance of substantial equivalence in FDA clearance

  • Q&A with regulatory experts

Register Here: https://forms.gle/bJCHjTSwdp4vuaqZ7ithAD

Event is free, but registration is mandatory

Contact : Aishwarya Varpe | aishwarya.varpe@venturecenter.co.in | 9156465137

Looking forward to your participation!