The Risk Analysis of Medical Devices

The aims and learning outcomes of this course are:

• To understand the Saudi Arabian requirements for risk analysis of Medical Devices and IVDs.
• To be able to actively participate in the Risk Analysis of Medical Devices and IVDs. 

This course is suitable for those who are: 

• Implementing the Risk Analysis requirements of ISO 14971:2019.
• Checking a Risk Analysis meets requirements of CE and SFDA.
• Quality Engineers and/or Regulatory Professionals.

Following completion of this course, participants should:

• Be in a position to write a risk procedure and a risk policy.
• Understand the value of a risk plan and be able to develop a basic plan for a medical device.
• Be able to actively participate in risk management of a medical device.
• Be in a position to create an FMEA and risk report.
• Be able to develop a post-market surveillance plan and associated reports. 

This five module course is held live in an online lecture theatre and delivered with a PowerPoint presentation.  All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course.  There are exercises included in order to ensure the course contents are fully understood and the opportunity is available for participants to ask questions.

OC115 explores the requirements of Risk Analysis and is broken down into 5 modules.

1. Introduction.
2. Plan.
3. Analysis.
4. PMS.
5. Vigilance.