Application of the In Vitro Diagnostic Directive Training Course

BSI’s “Application of the In Vitro Diagnostics Directive” 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.  

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.

Learning objectives

• 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
  

Benefits of attending this course?

• Take the first steps towards ISO 13485 accreditation
• Understand how you can better meet customer and regulatory requirements
• Find ways to increase efficiency and cost savings through quality management
• Monitor supply chains to achieve continuous improvement
• Develop safe and effective medical devices
• Motivate employees through CPD.