Based on Medical Device Management Systems
Based on Medical Device Management Systems
To keep quality management system standards relevant to the community of users, ISO 13485, the internationally recognized quality management system standard for medical devices industry, underwent major changes by the Standard Body and the revised medical standard ISO 13485:2016 was published on February 25, 2016.
This two-day training is to highlight the significant changes that affect registrants within the scheme, to help organisations understand some of the changes, how the changes may impact them, and how to audit against the revised ISO 13485 standard.
2 Days Instructor-led training
This course is ideal for Quality and Regulatory Managers/Supervisors, Product Designers, Management Representatives and Consultants, Internal Auditors and Consultants.
Having prior knowledge and understanding of the Quality Management System - ISO 13485 Standards and/or experience in medical device operations.
Written examination will be conducted at the end of the course. Participants will receive a certificate upon completion of course.
For any any enquiries, please fill up the adjacent form.