QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES

This course is for Perth-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 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 that provide product and/or services to such organisations.

Participants will gain knowledge and learn process steps to facilitate the implementation of 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.

Participants

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, researcher, start-up, supplier or a graduate with interest.