This course is for MedTech and HealthTech organisations planning to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Your organisation may be involved in one or more stages of the life-cycle such as design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.
Participants will gain knowledge and learn process steps to enable you to commence your journey to implementing an effective QMS aligned with or certified to ISO 13486:2016.
Applying ISO 13485 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits and commercial success.
- 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
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 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. On-site parking at additional cost.
MTPConnect and SeerPharma are committed to delivering this training, despite the COVID-19 restrictions in Australia. Planned classroom sessions may be postponed or moved to Zoom. However, places are limited so register ASAP to secure your seat risk-free. If we set new dates or change delivery mode and you can't/don't wish to attend, you are entitled to a full refund.
Classroom Sessions and Registration
Sessions will commence at 9am and finish by 5pm each day, local time.
|City||Dates||Venue||Register (credit card)|
|Sydney||13,14 & 16,17 Feb. 2023|| University of Sydney
|Melbourne||20-23 Feb. 2023|| University of Melbourne
Online (Zoom) Sessions and Registration
Sessions open to anyone, anywhere in Australia and will commence at 9am and finish by 5pm each day, Melbourne time.
|Dates||Register (credit card)|
|27,28 & 30,31 Mar. 2023||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.