BEGIN:VCALENDAR PRODID:-//Compnay Inc//Product Application//EN VERSION:2.0 METHOD:PUBLISH BEGIN:VEVENT DTSTART:20241029T053000Z DTEND:20241029T063000Z DTSTAMP:20260414T205000Z UID:dd7bec3d-df01-41d2-b219-7ab35b72eef9 CREATED:20241021T223500Z X-ALT-DESC;FMTTYPE=text/html:

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:

 

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:

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!

DESCRIPTION: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 ... LAST-MODIFIED:20260414T205000Z LOCATION:Online (Zoom Platform)... SEQUENCE:0 STATUS:CONFIRMED SUMMARY:Are you looking to understand the regulatory landscape for medical devices in the US? Join our awareness talk on "Understanding Medical Device Regulations in the US Market," where we will provide key insights into FDA requirements, with a focus on substantial equivalence and the 510(k) process. TRANSP:OPAQUE END:VEVENT END:VCALENDAR