Application of the In Vitro Diagnostic Directive Training Course

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.

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

Become an IVD Directive implementation expert today,

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 

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.

What's included?

  • You will gain 24 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments