A required part of conformity assessment and CE-marking is the need for a Technical File (called a Design Dossier for high risk devices), which includes the collation of supporting information about your IVD device. Learn how to assemble this and other types of required information, so you can CE Mark your device in Europe. You’ll also learn potential changes that may impact your Technical Documentation under the proposed future IVDR.
Who should attend?
- Quality assurance or regulatory personnel involved in compiling technical documentation and design dossiers
- Product design personnel
- Research and development for IVDs intended for the European market
What will I learn?
On completion of this training, participants will:
- Gain confidence in the requirements for technical documentation under the current European IVD Directive
- Review technical files and create new files to support IVD products
- Better prepare by understanding what may be expected by the future IVDR and Notified Bodies for technical file content during reviews
- Grasp how standards and guidance can be used to improve technical documentation
- Avoid incomplete Technical Files which can result in unexpected delays or prevent market entry
- Know what is expected by Notified Bodies for technical file content during reviews and be better prepared.
What is included?
- Training course notes
- Lunch and refreshments
- Certificate
