Overview
This course provide key QMS principles that facilitate global alignments for medical device quality management systems and to gain knowledge of applying the principles of QMS to implement in their workplace. This training course is developed by qualified experts who have several years of quality assurance experience in healthcare products.
Note that the course can be applied with/without Design and Development requirements. Please contact us for more details.
Learning Objective
Principles of ISO 13485 Risk based approach Quality Management System.
Understanding on how to meet regulatory requirements ensuring patient safety.
Clause by Clause guidance of each requirement with details explanations with interfaces and link between each clause requirements.
Target Audience
This course is suitable for anyone who is involved with medical devices and who has responsibility for developing or working or involved with the implementation of the standard.
This course can also serves as a comprehensive refresher course that should be completed annually to keep employees QMS compliance knowledge up to date.
Facilitation
This course can be run as a live classroom or virtual (synchronous) instructor-led training.
eLearning mode is available for busy learners. Learners can access and complete the learning topics and attempt course quizzes of course for a month upon date of signing up.
Please contact us for details.
Certificates
On completion, learners will be awarded certificate of completion issued by Ascelon qualified facilitator.