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.

Risk Management for Medical Devices

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 on 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.

A digital credential (badge) will be issued from Credly on e-mail after the quiz assessment is passed.

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.

Courses, Dates and Venue

This 1-day ISO 14971 course is part of a 3-day Medical Device training event run by SeerPharma in Perth.

We are also running a 2-day training course on ISO 13485 - Quality Management System Requirements for Medical Devices at the same venue on the two days prior to this ISO 14971 course. You are also welcome to register for one or both.

Each day commences at 9am and finishes by 5pm, local time.

Course and Dates Venue
ISO 13485 (2 days)
Mon 30 Nov & Tue 1 Dec 2026		 Harry Perkins Institute of Medical Research (North)
6 Verdun Street
Perth WA 6000
Getting to the Perkins and parking information
ISO 14971 (1 day)
Wed 2 Dec 2026
 
Cost

With support from the WA Life Sciences Innovation Hub, you only need to pay a small fee* to attend this fully catered training course. Upfront payment will be required to register and participate. On-site parking at additional cost.

  • Early bird pricing per person (exc. GST) to 31 October 2026:
    • ISO 13485 + ISO 14971 - 3 days - $1,000
    • ISO 13485 - 2 days - $800
    • ISO 14971 - 1 day - $400
  • Full pricing per person (exc. GST) from 01 November 2026:
    • ISO 13485 + ISO 14971 - 3 days - $1,250
    • ISO 13485 - 2 days - $1,000
    • ISO 14971 - 1 day - $500

*SeerPharma standard pricing for classroom training is $850 per day, so this represents excellent value.

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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