This course is for manufacturers and companies intending to manufacture medical devices and is their first step on the path to ISO 13485:2016 certification. It is suitable for manufacturers and companies with existing quality system certifications (such as ISO 9001:2015) as well as those with no existing certifications. It is also applicable to staff in companies with existing ISO 13485:2016 certification who have a role in implementing the system.
Participants will gain knowledge and learn process steps to enable them to effectively implement a quality management system and to meet the requirements for ISO 13485:2016 certification.
- Overview of Quality Management Systems, particularly ISO 13485:2016
- Benefits of quality system certification and of alignment
- Purpose, structure and requirements of ISO 13485:2016
- Quality Risk Management for medical devices
- Management Responsibility
- Resource Management
- Product realization
- Measurement, Analysis and Improvement
- Overview of application process for ISO 13485:2016
- Development of documentation required for ISO 13485:2016
- Preparation for applying for ISO 13485:2016
This course is open to anyone interested in learning more about the application of ISO 13485:2016 requirements and benefits of a quality management system for medical devices. You may be a subject matter expert, in research, in a start-up, a supplier or a graduate with interest.
Format and Course Length
The training will be delivered as face-to-face instructor-led workshop in cities around Australia. Each delivery will be a mix of theory and interactive case studies and workshops to accelerate your learning with practical skills. Each delivery will run over 4 days with group participation exercises and periodic breaks to keep you engaged.
What Do I Need?
You just need to attend with a positive attitude and willingness to participate. SeerPharma will provide all the materials (pens, notepads, copies of the presentations/exercises, handouts). Catering is also included.
This training is supported by the REDI initiative, powered by MTPConnect so you only need to pay a small co-contribution of $440 (including GST) to attend this 4-day workshop. Upfront payment will be required to participate.
MTPConnect and SeerPharma are committed to delivering this training, despite the COVID-19 restrictions in some States of Australia. Sessions will be postponed where required and delivered either face-to-face or online at a later date. Please register to secure your place.
Sessions and Registration
|City||Dates||Venue||Register (credit card)|
|Adelaide||Postponed||Precinct Conference Centre||Click here|
|Hobart||Postponed||Salamanca Inn||Click here|
|Perth||20-23 September 2021||Technology Park Bentley||Click here|
|Brisbane||11-14 October 2021||View Hotel Hamilton||Click here|
|Melbourne||8-11 November 2021||View Hotel St Kilda Rd||Click here|
|Sydney||22-25 November 2021||View Hotel Nth Sydney||Click here|
Sessions will commence at 9am and finish by 5pm each day. Please arrive early so we can start on time.
Not sure if ISO 13485 training is right for you?
Undertake our FREE online Quality Management System (QMS) Primer to understand the QMS basics first.
Other workshops available under the MTPConnect REDI initiative
Still have questions? Please contact us to discuss your interest and how we can help.