Clinical Evaluation of Medical Devices

The aims and learning outcomes of this course are:

• To understand the Saudi Arabian regulations regarding the Clinical Evaluation of Medical Devices in their organisation.
• To appreciate the EU and global requirements of the Clinical Evaluation of Medical Devices.

This course is suitable for those who are:

• Implementing a Clinical Evaluation in their organisation.
• Checking a Clinical Evaluation meets requirements of CE and SFDA.
• Quality Engineers and/or Regulatory Affairs professionals.

Following completion of this course, participants should:

• Have an appreciation of the requirements for Clinical Evaluation, post-market clinical follow-up, post-market surveillance and vigilance.
• Recognise where Clinical Evaluation fits in the legal framework.
• Be able to continuously update the Clinical Evaluation report practically.
• Conduct post-market clinical follow-up and post-market surveillance.
• Write an SSCP, a PSUR and a PMS plan and report.
• Conduct vigilance and setting limits and recognise trigger points.
• Understand QMS considerations, additional procedures and what they should cover.

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.

This course works through the Clinical Evaluation requirements and is broken down into 5 modules.

1. Introduction.
2. Plan.
3. Data.
4. Investigation and PMS.
5. Vigilance.