Precision and clarity in your regulatory plan is the key to a successful production and scale-up journey for medical devices.

Navigating the regulatory pathway is notoriously difficult. From understanding complex compliance requirements to managing different guidelines across various jurisdictions, many founders and researchers struggle to determine the right steps for their specific projects.

This full-day, hands-on masterclass is designed to help you stop "palming off" regulatory concerns to external experts and instead build a robust internal toolkit. By mastering design control, risk minimisation, and study optimisation, you can protect your reputation and significantly increase your chances of successfully accessing the market.

Eligibility applies*.

What to Expect

Delivered in partnership with The Adjutor Group, this workshop covers the full product cycle - from initial design and development to regulatory compliance and Quality Management Systems (QMS).

Participants will walk away with the ability to:

Identify Product Classification: Determine your likely category under the TGA framework (Class I, IIa, IIb, III, etc.).
Understand Impact: See how your classification dictates evidence requirements, clinical trial needs, and design control.
Build a Roadmap: Begin outlining a tailored regulatory strategy based on your product’s current development stage.
Global Navigation: Distinguish between Australian and international frameworks (e.g., FDA 510(k), CE mark) and understand how they affect your planning.
Practical Execution: Explore essential first steps including conformity assessments, documentation, and engaging with regulatory consultants or NATA labs.
Strategic Integration: Learn to weave regulatory planning into grant writing, business development conversations, and QMS development.

PANEL DISCUSSIONS:

Panel 1. Getting Regulatory Right Early

Panel 2. From Strategy to Execution

Who Should Attend?

This masterclass is specifically designed for:

Researchers, developers, and engineers working on Medical Devices or Software as a Medical Device (SaMD).
Clinical entrepreneurs and founders who have are working through their proof-of-concept stage (laboratory prototype or clear blueprint) looking to understand how to move towards product development and establishing clinical trial.
Applications are Subject to Eligibility

*Eligibility

This hands-on workshop provides the opportunity for researchers, developers and founders to work directly with experts from reputable Contract Research Organisations, to gain insight and professional advice from industry professionals specific for their research project in moving from proof of concept to regulator ready.

All successful applicants will receive confirmation of placement prior the workshop based on eligibility and project readiness.

Contact the host of Building Regulatory and Trial Readiness for Medical Devices & SaMD - HealthTech Hub Masterclass