ISO 13485:2016 Auditor Training

Who is this course for?

This course is designed for professionals aiming to master the skills required for auditing medical device quality management systems under ISO 13485:2016. It is ideal for individuals who are responsible for ensuring compliance with industry standards and regulations, and those seeking to enhance their auditing capabilities in the medical devices sector.

Participants will gain comprehensive knowledge and practical insights into the intricacies of auditing, the standards’ requirements, and the necessary steps to conduct effective audits. This training is crucial for those looking to advance their careers in quality management systems, particularly within organizations that design, develop, or manufacture medical devices.

Target audience:

• Quality Assurance Managers and Officers

• Regulatory Affairs Professionals

• R&D Engineers involved in medical device manufacturing

• Internal Auditors and Consultants

• Compliance and Risk Management Officers

• Anyone aspiring to become a certified ISO 13485:2016 Auditor