This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.
"The course has been included in the list of registered public courses under the Reindustrialization and Technology Training Program."
Each company is subject to a funding ceiling of HK$500,000 in each financial year at the course commencement date.
Please click "here" for the details of RTTP.
How will I benefit?
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of the standard
What will I learn?
On completion, you should gain the knowledge and skills to:
• Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
• Identify the relationship between ISO 13485:2016 and European Medical Device Directives
• Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
What is included?
- You will gain 8 CPD points on completing the course
- Training course notes
- An internationally recognized BSI Training Academy certificate
HK$ 980 ONLY (after RTTP reimbursement)