Application of the In Vitro Diagnostics Directive
Our Application of the In Vitro Diagnostics Directive three-day training 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.
There are no pre-requisites to take this course, but it is advantageous to have a basic knowledge of quality management systems for the IVD industry or experience of the manufacture, design, marketing or use of IVD devices.
Who should attend?
- Regulatory & quality personnel
- People new to companies or roles impacted by the IVD Directive
- Distributors of IVD’s
- Own Brand labellers (OBL)
- Start-up companies
- R&D personnel
- Internal auditors
- 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
- Learn to apply the requirements of the directive to create technical documentation to support the product throughout its lifecycle
- Understand the requirements of IVD Directives
- Gain a new perspective of CE marking
- Learn how to define criteria and responsibilities under the directives in your organization
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