08:00 - 16:00
In Person or Webinar (to be determined)
This is the extended course on how to run a clinical evaluation and write a Clinical Evaluation Report according to the Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev. 4 2016.
Norway Health Tech and our partner Qmed Academy would like to begin the Clinical Evaluation and Assessment Training Series with this first course taking a deep dive into the Clinical Evaluation process.
During this course you will learn how to run a clinical evaluation and write a Clinical Evaluation Report according to the Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev. 4 2016. We will have the following learning objectives:
• Introduction to Clinical Evaluation – the regulation and guidelines behind the process
• Literature Search principle and how to manage
• Workshop on Literature Search strategies
• How is the Clinical Investigation linked to the Clinical Evaluation and what is the difference?
• How to set up a Post-market clinical follow-up program
• Workshop on how to find input data to the Post-market clinical follow-up section
• What other technical documents leads into the clinical evaluation such as usability
• How to write up and update a Clinical Evaluation Report
• Member NOK 5 500
• Cluster Member NOK 6 000
• Non Member NOK 7 000
Clinical Course Series (includes Clinical Evaluation (8hr), Clinical Benefit – Risk Assessment (1hr) and Clinical Investigation (8hr):
• Member NOK 10 000
• Cluster Member NOK 12 000
• Non Member NOK 14 000
This course is for Medical Device specialist working within Regulatory Affairs, Clinical Affairs or similar that are about to write up a Clinical Evaluation Report for the first time. Or experienced Medical Device Specialists that needs a brush up on the new Medical Device Regulation and the requirements specific to the Clinical Evaluation process.Register