This three day course has been designed to enable participants to explore the IVD Directive, gain a greater understanding of the requirements and thus enable IVD devices to be placed on the European market.
How will I benefit?
Participants will be able to apply the requirements of the directive to create technical documentation to support the product throughout its lifecycle. Managers and quality/regulatory professionals responsible for all aspects of IVD CE marking as well as internal and external auditors, will benefit from attending this course.
Who should attend?
- Regulatory & quality personnel
- People new to companies or roles impacted by the IVD Directive
- Distributors of IVD’s
- Virtual manufacturers
- Start-up companies
- R&D personnel
- Internal auditors
What will I learn?
On completion of this training, participants will be able to:
- Explain the European CE marking approach for IVD’s including its legal and operational basis
- Describe the structure and scope of the IVDD including classification and conformity routes
- Apply the essential requirements including labelling and develop suitable technical documentation
- Identify the regulatory significance of risk management and process validation
- Combine knowledge gained from the course with audit qualifications to conduct compliance audits of their organization and suppliers
- Explain the role and importance of performance evaluation including application of the Common Technical Specification (CTS)
- Interpret the criteria for reporting adverse incidents under the vigilance system
- Define the manufacturers regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body
What's included?
- You will gain 24 CPD points on completing the course
- Training course notes
- Lunch
- Refreshments
Become an IVD Directive implementation expert today,
