Medical Software Regulatory Requirements – 1-Day Workshop
November 26 @ 9:00 am - 3:00 pm
The Johner Institute New Zealand, in collaboration with Te Tītoki Mataora and HealthTech Activator, is pleased to present the “Medical Software Regulatory Requirements” workshop in Auckland. This hands-on workshop will equip you with foundational knowledge in regulatory standards for medical software, addressing both “software as a medical device” (SaMD) and software integrated within medical devices (SiMD).
This one-day event offers an immersive learning experience aimed at helping you navigate the intricate regulatory landscape surrounding medical software. Our focus will be on practical applications of IEC 62304, an internationally recognized standard for medical device software development. Gain insights into effective development and compliance strategies that balance rigorous quality assurance with efficient software development processes.
What You Will Learn
This workshop will guide you through:
- Core Regulatory Concepts: Understand the essential standards, guidelines, laws, and directives governing medical software, along with how these regulations interact.
- Safety and Performance Principles: Learn the foundational elements of medical software safety and how to ensure ongoing performance.
- IEC 62304-Compliant Software Development: Explore compliant software development processes, including key verification and validation practices.
- Change Management under IEC 62304: Unpack the standard’s approach to managing development processes and change requests in medical software.
- Cybersecurity Requirements: Discover the specific cybersecurity requirements needed to safeguard medical software against emerging threats.
- Market Approval and Compliance: Get an overview of the market approval process and learn how to navigate regulatory updates effectively.
This interactive workshop encourages discussion and provides ample opportunity for questions, making it ideal for those looking to deepen their understanding of regulatory best practices.
Who Should Attend?
The workshop is designed for researchers, early-stage start-ups, and clinicians involved in developing medical devices or SaMD. Whether you’re a newcomer or looking to refresh your knowledge on regulatory frameworks, this workshop will provide valuable insights to support your product development journey.
Please Note:
- If you’re a researcher or clinician, choose the “Te Tītoki Mataora | MedTech Research Translation” ticket.
- Start-up companies should select the “HealthTech Activator” ticket.
Event Details:
- Date: November 26
- Location: Callaghan Innovation, Auckland
- Fee: $50 (includes GST and booking fee)
- Meals: Morning tea and lunch provided
- Registration Deadline: Register by 19 November 2024 to secure your place (limited to two participants per company/research group). A waitlist will be available once capacity is reached.
Meet the Presenter
The workshop will be led by Annett Arndt, CEO of Johner Institute New Zealand Ltd., who brings extensive expertise in regulatory requirements for medical software. Annett’s guidance will offer practical, actionable insights into IEC 62304 compliance and quality assurance.
Register
You can register here: https://www.callaghaninnovation.govt.nz/events/medical-software-regulatory-requirements-healthtech-activator/?utm_source=social&utm_medium=post&utm_id=HTA_webinars_CIPMD
