ISO 13485 Medical Device QMS Workshop

Starts:  Mar 27, 2023 09:00 AM (Sydney time)
Ends:  Mar 31, 2023 05:00 PM (Sydney time)
Associated with  National Space

This 4-day instructor course is just $440 per person (including food and drinks): Supported by the REDI initiative, powered by MTPConnect

 

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.

 

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
  • 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
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