To bring safe, compliant medical devices to market, understanding regulatory requirements for product design and manufacture is crucial.
Through a local and global lens, this BioForum will provide an overview of regulatory essentials for local manufacturers and medtech enterprises, examining key compliance considerations and why traceability and maintaining evidence is so important.
Leading manufacturer, Invetech will further examine the regulatory environment for onshore device manufacturing and highlight requirements as an operating ISO 13485 facility.
Sharing the journey of MeMed (Israel), Dr Oren Zarchin will share his insights and lessons learnt working with the FDA, challenges faced for novel device development, manufacture and clinical studies, and meeting compliance for US market access.
Don’t miss this opportunity to learn from leading industry experts to optimise your manufacturing pipeline.
The BioForum is a stand-alone event as well as Part A of the masterclass program. Masterclass participants are not required to register separately to attend.
Event details:
Date: Tuesday 30 May 2023
Time (AEST):
7:30am: Registration, tea & coffee
7:30am – 8:30am: Networking breakfast (in person only)
8:30am – 9:30am: Presentations (live streamed)
9:30am – 10:00am: Panel and Q&A (live streamed)
Venue: ACMI, Swinburne Studio, Federation Square, Melbourne VIC 3000
Format: Hybrid – in person and online.
Host: Jeff Malone, CEO, BioMelbourne Network
Registration (BioForum only):
In-person: Members $85; Non-Members $175
Online: Members $25; Non-Members $45
Cancellation policy for BioForum:
In person registration
- Full refund given up to 7 days prior to the event
- No refunds within 7 days of the event
Online registration
- Full refund given up to 3 days prior to the event
- No refunds within 3 days of the event
Unsure if your organisation is a member? Check our member directory
Kindly sponsored by the State Government of Victoria
For a more in-depth look at this topic, take a deep-dive into medtech manufacturing with our masterclass program Concept to Creation: The Roadmap to Medtech Manufacturing. The program includes this BioForum along with a full-day workshop and one-on-one advisory session.