From Innovation to Market: Navigating Medical Device Compliance

Bringing a medical device to market requires more than innovative design. Manufacturers must navigate complex safety, risk management and software requirements while preparing for increasingly rigorous conformity assessment expectations.

Join UL Solutions for an interactive technical workshop where our experts will share practical insights into IEC 60601-1, ISO 14971, IEC 62304 and related standards, helping you reduce compliance risks, avoid common pitfalls and improve market readiness.

UL Solutions is a global leader in applied safety science. We provide safety science expertise, testing and certification, and software to support customers in bringing safer and more sustainable medical products to highly regulated global markets. With technical and regulatory expertise, we help customers navigate global compliance requirements and develop safer, more secure medical technologies.

AUScelerate, Australia's leading independent, not-for-profit life sciences innovation accelerator is delighted to be an ecosystem partner for this event.

For queries on attending the workshop, please contact Amelia Vom (amelia.vom@auscelerate.org) or Wendy Yu (Wendy.Yu@ul.com).

Event Details

• Date: Monday, 30 November, 2026

• Time: 1:00pm - 5:20pm AEDT (1:30pm start)

• Venue: Discovery Studio, Aikenhead Centre for Medical Devices (ACMD)

Interactive Forum for Learning and Industry Exchange

Designed as an interactive forum, this workshop offers opportunities to engage with UL Solutions experts and industry peers, exchange experiences, discuss common compliance challenges, and explore practical approaches to product development, certification and market readiness.

Key Topics

·  Medical Device Safety and Performance (IEC 60601-1)

Understand key safety and performance requirements, common compliance pitfalls, and practical considerations for medical device development.

·   Risk Management Throughout the Product Lifecycle (ISO 14971)

Learn how effective risk management supports product safety, compliance, and successful project execution.

·   Software and Connected Medical Devices (IEC 62304)

Explore software lifecycle, Software as a Medical Device (SaMD), and cybersecurity considerations for modern medical technologies.

·   Preparing for Testing, Certification and Market Access

Discover strategies to prepare for conformity assessments, reduce project delays, and improve market readiness.

Agenda

Who Should Attend

• Medical device manufacturers

• R&D and product development professionals

• Software engineering teams

• Regulatory affairs professionals

• Quality and compliance managers

• Engineering and project leaders

Why Attend

• Gain practical insights from UL Solutions experts

• Better understand key safety, risk management and software requirements

• Identify common compliance challenges before they impact your project

• Improve readiness for testing, certification and market access

• Network with industry peers and exchange real-world experiences on product development and compliance challenges

Privacy Notice

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Register Today

Seats are limited and registration is required.

We look forward to welcoming you to this informative session and supporting your journey toward safer, compliant and market-ready medical devices.

Tickets

$49 per person (incl. GST). Includes afternoon tea and refreshments.
Registrations close 29 November unless sold out earlier.