When designing and developing new medical devices, understanding the regulatory requirements is essential in determining the pathway to commercialisation.

This course will provide an overview of the global regulatory environment for medical devices, the difference pathways to market, and how to design a medical device in line with these regulations and international standards.

You will learn how to compile an effective regulatory strategy for new devices, understand what are intended use statements and why they are important and how to apply the classification rules for new devices.

Medical Device Engineer performing engineering work

Content
  • The Global regulatory landscape for medical devices
  • What is the Intended Use statement and why is it important
  • Classification rules for medical devices
  • How the GSPR checklists/Essential Principles checklists drive medical device design and development
  • ISO 14971:2019 – the role of risk management in design and development of medical devices
  • Summary of Quality Management Systems; ISO 13485:2016, 21 CFR Part 820, MDR and IVDR
  • International standards, normative references and ‘State of the art'
  • Project management for design and development of medical devices
  • Designing a medical device in line with regulatory and international standards
  • How to compile a Technical File (Europe, USA, Australia)
  • How to compile a regulatory strategy
Participants

This course will benefit you if you are involved in the design and development of new medical devices. You may be working in Design/Engineering, Regulatory Affairs, Quality Assurance or Quality Control.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 half-day sessions, with breaks.

A digital credential (badge) will be issued via Credly on e-mail to recognise successful training completion.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Each participant will attend both full-day sessions:

 Sessions  Dates  Times
 Day 1  1 April 2025  9:00am-12:30pm
 Day 2  2 April 2025  9:00am-12:30pm

Times are based on Melbourne, Australia.

Fee and Discount
  • AUD $700 (exc. GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

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Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions