Medical device manufacturers and sponsors need to understand and comply with the current Risk Management standard requirements of ISO 14971:2019 (Application of Risk Management to Medical Devices).
This course will provide you with the knowledge, skills and tools to implement a risk management process in compliance with the ISO 14971:2019 standard as part of your Quality Management System.
At the end of this course you will be able to:
- Understand the importance of risk management processes
- Understand the success factors for an effective risk management process and the benefits it delivers
- Develop risk management strategies for products and processes
- Understand the application of the risk management process
- Be able to conduct a risk assessment in accordance with the standard
- Assess the risk management process within your organisation against the standard
- Understand the relationship between ISO 14971:2019 and ISO 13485:2016
Content
The course will provide a short introduction to the risk management process required in a Medical Device organisation followed by practical advice to help you implement risk management in line with ISO 14971. It will cover:
- An approach for the implementation of risk management as part of a Medical Device Quality System
- The risk management concepts within ISO 14971
- An overview of how risk management practices are used to support quality and compliance programs in Medical Device companies
Participants
This course will assist organisations preparing for ISO 13485 (re)certification, as risk management in compliance with the ISO 14971:2019 standard is mandatory as part of that QMS certification process. It will also be of interest to businesses that supply services or materials to ISO 13485 regulated medical device companies. Business types that have benefited from ISO 14971 training include:
- Medical device design and manufacturing groups
- Medical device sponsors whose products are manufactured in other regions and then distributed in Australia and Europe
- Suppliers to medical device companies looking to gain a competitive edge
Format and Course Length
This training will be live, face-to-face in a classroom environment. Delivery will be a mix of theory and interactive case studies and workshops to accelerate your learning with practical skills. The course is a single delivery that will run 1 day with group participation exercises and periodic breaks to keep you engaged.
An online quiz assessment will be issued by SeerPharma on e-mail after delivery of the course is complete.
Catering
Catering will be provided and is included in the cost below.
What Do I Need?
You just need to attend with a positive attitude and willingness to participate. SeerPharma will provide you with the training materials via e-mail.
You may be interested to know we're running a 2-day training course on ISO 13485 - Quality Management System Requirements for Medical Devices at the same venue Monday & Tuesday before this course.
Dates and Venue
Each participant attends one day, commencing at 9am and finishing by 5pm, local time:
| Dates | Venue |
| Wednesday 02 Dec 2026 | Harry Perkins Institute of Medical Research (North) 6 Verdun Street Perth WA 6000 Getting to the Perkins and parking information |
Cost
With support from the WA Life Sciences Innovation Hub, you only need to pay a small fee* to attend this fully catered 1-day training course. Upfront payment will be required to register and participate. On-site parking at additional cost.
- Early bird pricing to 31 October 2026: $440 (inc. GST)
- Full pricing from 01 November 2026: $550 (inc. GST)
*SeerPharma standard pricing for classroom training is $935 per day (inc. GST), so this represents excellent value.
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Contact us to discuss your interest in a public or private delivery of this course.
