This course aims to provide you with an understanding of ISO 13485 2016 Medical Device Quality Management System
Description
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organization can be involved in one or more stages of the life-cycle, including 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 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to all organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
Objectives
The programme aims to provide delegates with learning how to:
Explain the structure and terminology of the management system standards
Describe the key revisions or changes compared to previous ISO 13485
Explain and aware of activities involved for maintaining certification
Audience
- Managing Directors
- Chief Executive Officers
- General Managers
- Medical representative/Safety Officers
- Relevant Departmental Managers (QA, Legal, Production, etc)
- Auditors
- Consultants
- Practitioners
- Medical Device Committee Personnel
Classroom (2 Classes) 2 Days
43240443English