08:00 - 16:00
In Person or Webinar (to be determined)
Understanding the requirements for conducting clinical investigations with a medical device and stay compliant to the Medical Device Regulation.
During the last course in our Clinical Evaluation and Assessment Training Series, Norway Health Tech and our partner Qmed Academy will be addressing Clinical Investigations.
This course will walk you through the requirements and practicalities conducting clinical investigations with a medical device. At the end of the course you should know the general principles and what to look out for of pitfalls when preparing, conduct and closing your study. We will have the following learning objectives:
• Introduction to the Medical Device Regulation and Clinical Investigations
• What Ethical principles should be considered before starting up a study
• Patient Consenting – how to do
• What is Sponsor responsibilities
• Clinical investigation planning
• What are Investigator responsibilities
• How to conduct and manage a Clinical investigation efficiently and with high compliance
• Remote SDV (under Covid-19 if still relevant) – new European requirements issued by EC
• How to put together a good Site file
• Process of Suspension, termination and close out of studies
• Know the Safety Reporting pathways under MDD and MDR
• 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
Individuals working within the medical device space and are facing the requirement of collecting new clinical evidence to obtain your CE mark this would be a course for you.
The course will be conducted to start ups and medtech specialists that needs to learn about clinical investigations.
As the course is based on the requirements in MDR and the new ISO 14155:2020 it will also be useful for people who want a brush up on the new requirements and guidelines that most recently has come out.