Online & Self-Paced Medical Device Risk Management & ISO 14971:2019 Training Course | CQI, IRCA & Exemplar Global Certified

This CQI, IRCA & Exemplar Certified Online & Self-Paced Medical Device Risk Management & ISO 14971:2019 Training Course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019.

Learning Objectives

There are 6 course objectives covered:

1. Explain the history, purpose and structure of ISO 14971 and its relationship to ISO 13485 and the EU & US FDA regulations
2. Define the key terminology used throughout ISO 14971
3. Describe the elements of an effective risk management process
4. Describe the different techniques that support risk analysis
5. Explain the requirements for updating the risk assessment based on information collected and reviewed
6. Outline the role of ISO/TR 24971 in risk management

Course Certification (No. 2415)

This course is CQI, IRCA & Exemplar Global Certified. Successful completion will entitle each Learner to receive a digital CQI, IRCA & Exemplar Global Recognised Certificate of Completion.

Who Should Attend?

This course is aimed at anyone working in the medical device sector that wants to gain an understanding of risk management based on ISO 14971:2019, including:

• Design & Development personnel
• Quality / Engineering / Technical / Production personnel
• Regulatory affairs
• Internal / Lead / Supplier Auditors

Assessment Methodology

In order to successfully complete this online course, each Learner will need to:

• Complete the online course modules and obtain 70% or higher in the assessments (MCQ-based)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

• Course Access for 90-days
• Phone & Email Support (Virtual Instructor)