Navigating Global Medical Device Regulation

The Victorian Medtech Skills and Devices Hub is working with industry, academia, and government to build future-ready courses and education programs, creating job-ready graduates and more specialised Medtech professionals.Through our education offerings, we will improve the international competitiveness of the Victorian Medtech sector, creating skilled job opportunities and improving access to advanced medical care for Australians.

Victorian Medtech Skills and Devices Hub

Learn how to develop a robust regulatory plan that aligns with your go-to-market strategy in this engaging one-day course.

The Victorian Connected Health Innovation and Commercialisation Centre (CHICC)

Regulation can make or break your medtech innovation.Learn how to develop a robust regulatory plan that aligns with your go-to market strategy in Navigating Global Medical Device Regulation, a new learning opportunity supported by the Victorian Medtech Skills and Devices Hub (VMH).Delivered by ANDHealth and hosted by CHICC, this practical, one-day, face-to-face course is designed for:<ul><li>Researchers</li><li>Start-ups and SMEs</li><li>Medtech &amp; early career regulatory professionals</li><li>Clinical entrepreneurs</li></ul>Facilitated by leading medtech regulatory expert Paul Clark, Director of Eleven Borders, this course will help you understand medical device regulations in Australia, the US, and the EU and how to align your product development strategy accordingly.You’ll gain practical knowledge on:<ul><li>What regulators expect at each stage of development</li><li>How to define and classify devices across regions</li><li>Building a global regulatory strategy</li><li>Integrating compliance during design and development</li><li>Avoiding delays, redesigns, and regulatory missteps</li></ul>Benefits include:<ul><li>Better understanding of device, software as a medical device (SaMD), and AI requirements</li><li>Better compliance with global standards</li><li>Reduced production risks and defects</li><li>Greater trust from investors and customers</li></ul>Bonus Value: Includes a free 1:1 consultation with a TGA-trained ANDHealth expert to guide your product’s regulatory pathway.Refreshments including a light lunch will be provided.Pricing:To improve accessibility and support workforce development in the medtech sector, VMH is subsidising each registration – reducing the program cost from $550 per person to:<ul><li>VMH-Supported – General: $300 | Student: $200</li><li>Early Bird – General: $250 | Student: $150</li><li>Group bookings (3+ participants): Contact us for discounted rates</li></ul>Spaces are limited – register now to fast-track your product’s regulatory and commercial success. FacilitatorsPaul L. Clark | Founder and Director, Eleven BordersPaul L. Clark is a seasoned veteran in the Medical Device (MedTech) industry with over 30 years of experience. He has a diverse background, having worked in various capacities such as regulatory affairs, quality management, clinical research, product development, and operations.Throughout his career, Paul has worked for regulatory agencies in Australia, Canada, the US, and Europe, and has also worked with startups and medium-sized MedTech companies in Australia and the US. He possesses a unique skill set that combines his regulatory, quality, and clinical background with proven commercial experience, including the successful launch of MedTech products in the ANZ market.Paul's experience spans a range of active and non-active MedTech technologies, including implantable devices, cardiovascular, ophthalmic, drug delivery, renal, gastrointestinal, surgical, intensive care, wound care, imaging, mental health, monitoring devices, Software as a Medical Device (SaMD), wearable technologies and other digital health technology.He has direct experience working with the TGA as a medical device evaluator, has been a CE Lead Auditor with TUV SUD, worked with the Canadian Medical Devices Bureau, and has dealt directly with the FDA for over 30 years. Paul has also worked directly with a number of startup MedTech ventures both in the US and Australia, and as an independent consultant/founder of Paul L Clark and Associates and Eleven Borders Pty Ltd.If you need help navigating the global regulatory landscape throughout concept/feasibility, product development, commercialization, and post-market, Paul is the person you should talk to. His expertise traverses the regulatory borders of all key markets, including Australia, the US, the EU, the UK, Canada, and Asia.

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Guest arrival, registration, tea and coffee

Course proceedings

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