Development and evolution of technologies is always faster than the regulations that govern products and services leveraging the technologies. For medical devices, this dynamic presents a constantly changing and challenging environment for both manufacturers and regulators.
If you're new to the medical device industry or needing a quick refresher, this course introduces the current ISO 13485:2016 Quality Management System (QMS) requirements and how they can be applied. You'll gain insights into key clauses and concepts that underpin an effective QMS and learn what it takes to implement an effective QMS aligned with ISO 13485:2016.
- Overview of Quality Management Systems, particularly ISO 13485:2016
- Documentation requirements
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis and Improvement
Participants
This course will assist people and organisations with plans to align with or gain certification to the ISO 13485 Standard; whether you have a medical device idea, work in research with a view to commercialising or are establishing a start-up. It will also support medical device industry personnel needing refresher training.
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 x half-day sessions over 2 days. Breaks are included.
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 | 13 February 2024 | 9:00am-1:00pm |
| Day 2 | 14 February 2024 | 9:00am-1:00pm |
Times are based on Melbourne, Australia.
For Melbourne customers, you may be interested in our subsidised face-to-face ISO 13485 session in April. Click here to learn more.
Fee and Discount
- AUD $700 (exc. GST) per participant
- A 10% discount applies for 3 or more participants from the same company
If you can't see the booking window to select tickets below, please click here.
Contact us to discuss your interest in a public or private delivery of this course.
