M15 - IVD Regulations, Quality & Product Safety - IVD CE Marking Technical File Compilation & Management

About this course

One of the major aspects of CE marking for IVDs is the compilation and management of appropriate technical documentation. This course takes you through the requirements for IVD technical files, outlines common technical specification, harmonized standards and the best practices adopted for maintaining appropriate compliant technical files.

Who Should Attend

• Senior management
• Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel
• Organizations preparing ‘own brand’ or ‘private label’ devices
• Distributors of IVDs

Course outline

This is a new course offering for Medical Devices.

For more information please call our team on +441142 541270

E-mail our training and education team at: [email protected]

Venue

Manchester - Venue to be confirmed

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nunc congue, velit id luctus laoreet, purus mi luctus lacus, quis faucibus mauris ipsum a enim. In sed eros ante, id luctus diam. Cras quis justo consectetur sem dignissim pharetra.

Tutors

The tutor for this course is as follows:

• 

  Sarah Couch
  Medical Devices Consultant
  

  • [email protected]
  • +44 (0) 1143 600868

What you've said

Feedback to follow