COURSE CONTENT

• ISO 13485 :2016 standard review
• Understand ISO 13485:2016 Medical Device Quality Management System audit and regulatory requirements
• Internal auditing (including audit planning, auditing methodology, auditing skills, reporting and CAPA follow up

OBJECTIVE

• To understand the application of Medical Device Quality Management System.
• To understand the importance of internal auditing and the responsibilities of internal auditors
• To plan and organize an internal audit

WHO SHOULD ATTEND?

• Person in charge of establishing and implementing ISO 13485:2016
• Management Representatives
• Person wishes be trained as ISO 13485:2016 internal auditors
• Person is seeking for learning essential knowledge in quality management control in medical device industry
• Medical Device professionals interested in conducting first party, second party, and/or third party audits

CERTIFCATE AND CPD:
Certificate of successful Completion will be awarded delegates who have attended full course. An e-Certificate will only be granted. You may be able to claim CPD hours for your membership at professional bodies.

** RTTP (Reindustrialisation and Technology Training Progamme) Recognized Training Course **

RTTP Pre-approval training courses, eligible company could apply for RTTP funding in order to receive up to 2/3 course fee reimbursement for each employee.

Coupon:

Available