This training covers the regulatory framework governing CE marking of medical devices and clinical investigations in the EU.
Changes coming to regulations and guidance on Medical Devices Clinical Investigations
First of all we consider the Regulatory Environment for medical devices including the currently applicable Medical Device Directives and the changes coming in with the new Medical Devices Regulations which will apply in the next few years.
We can also cover the FDA Regulations governing medical devices in the US.
We then turn to Clinical Investigations with Medical Devices and their role in demonstrating Conformance for CE marking.
The main focus of the course is ISO14155, which provides guidance on Ethical Considerations, Planning and Management of Clinical Investigations and Roles and Responsibilities. There is also an overview of the changes anticipated with the forthcoming new version of ISO14155.
Who is it suitable for?
This course is suitable for those who need an introduction to GCP for clinical investigations, for example Project Managers, monitors, investigators, sponsors.
Objectives:
To provide delegates with an understanding of:
- The regulatory framework governing clinical investigations
- Overview of ISO14155.
- Changes coming to regulations and guidance on Medical Devices Clinical Investigations
Training Methods:
Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies. This course will also be supported by additional resources available from our website.
Duration:
1 day
Example Content:
Regulatory Environment
- Medical Device Directives
- New Medical Devices Regulations
- FDA Regulations
Clinical Investigations with Medical Devices
- Deomonstrating Conformance
- When is a Investigation Required?
- Clinical Investigations with CE marked devices
ISO14155
- Ethical Considerations
- Responsibilities
- Ethics committee review
- Informed Consent
- Planning
- Design and Statistical Considerations
- Risk Assessment
- Documentation required
- Management of the CI
- Conduct
- Quality Management
- Risk Based Monitoring
- Adverse Events and Device Deficiencies
- Data management
- Audit
- Record keeping and retention
- CI Report
- Responsibilities
- Sponsor
- Principal Investigator
- New Version of ISO14155
- Key changes anticipated
- Design of Medical Device Investigations: Special Considerations
- Blinding and Randomisation
- Accountability
- Sterilisation
- Labelling
Please contact me for more information and to organise your course.
Click here to sign up to our mailing list.