Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation)

Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) is a seminar that covers topics such as:

• Overview of the MDR and IVDR
• Technical documentation/file content
• Quality management system (QMS)
• Compiling the technical documentation
• Labelling
• Notified Body experience
• Conformity assessment
• Post market surveillance
• Requirements related to authorized representatives
• Person responsible for regulatory compliance
• Requirements for archiving technical documentation

Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) brings together:

• IVD regulatory affairs professionals
• Medical device regulatory affairs professionals
• Quality managers/associates
• R&D personnel creating technical documentation
• Business development managers
• Product managers

Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) is being held in London, United Kingdom on 10-11 Mar 2021.