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.
MTPConnect and SeerPharma are committed to delivering this training, despite the COVID-19 restrictions in some States of Australia. Some Zoom sessions have been scheduled and we hope to deliver classroom training in the future. Planned classroom sessions may be postponed or moved to Zoom because of COVID-19 restrictions. Please register to secure your place with no financial risk.
Format and Course Length
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 3 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 you with the training materials.
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.
Zoom Sessions and Registration
Zoom sessions will be delivered from Sydney. See below for local times (*Perth time in WA).
|State||Dates||Local Time||Register (credit card)|
|WA||26, 28 Oct. & 1, 4 Nov. 2021||8:00am - 4:00pm*||Click here|
|SA||30 Nov. & 2, 7, 9 Dec. 2021||8:30am - 4:30pm||Click here|
|TAS||30 Nov. & 2, 7, 9 Dec. 2021||9:00am - 5:00pm||Click here|
Classroom Sessions and Registration
Classroom sessions will commence at 9am and finish by 5pm each day, local time.
|City||Dates||Venue||Register (credit card)|
|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|
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.