Medical device manufacturers and sponsors need to understand and comply with the current Quality Management System (QMS) standard requirements of ISO 13485:2016.
This 2-day training course will provide you with the knowledge, skills and tools to implement a QMS in compliance with the ISO 13485:2016 standard.
At the end of this course, you will be able to:
- Know your legal obligations as a sponsor or manufacturer
- Understand the success factors for an effective QMS and the benefits it delivers
- Develop risk management strategies for products and processes
- Determine if your organisation is ISO 13485 audit-ready
- Develop plans to streamline your QMS and maintain practical compliance
Content
The course will provide a short introduction to the regulatory landscape of Quality for medical device companies followed by practical advice to help you implement a QMS across the four (4) key areas of ISO 13485. It will cover:
- The Regulatory Environment
- The ISO model for an effective process-based QMS
- The application and integration of a Quality Risk Management (QRM) framework
- Key areas of ISO 13485 (including changes in the 2016 standard)
- Management responsibility
- Resource management
- Product realisation
- Measurement, analysis and improvement
Participants
This course will assist organisations preparing for ISO 13485 certification (or re-certification to the 2016 standard). It will also be of interest to businesses that supply to ISO 13485 regulated companies. Business types that have benefited from ISO 13485 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
- Pathology companies
- 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 over 2 consecutive days 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.
Courses, Dates and Venue
This 2-day ISO 13485 course is part of a 3-day Medical Device training event run by SeerPharma in Perth.
We are also running a 1-day training course on ISO 14971 - Risk Management for Medical Devices at the same venue on the day after this ISO 13485 course. You are also welcome to register for one or both.
Each day commences at 9am and finishes by 5pm, local time.
| Courses 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 2-day 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.
