Posted: 21 September 2023
Event: 13 – 17 November 2023
Location: Superfloor Meeting Rooms, Melbourne Connect
Price: $440
Audience: Grad/post grad students, researchers or entrepreneurs interested in learning more about the application of ISO 13485:2016 requirements and benefits of a quality management system for medical devices.
This course is for Victorian-based Medical Device, MedTech and HealthTech organisations planning to provide medical devices and related services that consistently meet customer and applicable regulatory requirements of ISO 13485.
Your organisation may be involved in one or more medical device life-cycle stages such as design and development, production, storage and distribution, installation, servicing or associated activities (e.g. technical support). ISO 13485 can also be used by suppliers that provide products and/or services to organisations working in these stages.
Participants will gain knowledge and learn process steps to facilitate the implementation of an effective QMS aligned with or certified to ISO 13485:2016.
Applying ISO 13485 helps ensure that businesses deliver consistent good-quality products and services, ultimately improving customer satisfaction and contributing to commercial success.
Content
- 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 (ISO 14971)
- 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
