Webinar series:

Is your company ready for the digital future and compliance with In Vitro Diagnostic Regulation (IVDR 2022) and EU MDR (2024)?

Practical know-how; digital tools and processes needed

Sign up to receive an invitation to this free webinar series that will be hosted by Amin Gholiha, Data Ductus, in September and October 2020. The invitations will be sent out in August.

Topics that will be covered include:

  • GAP-analysis; Data collection plan; Validation plan; Internal process change plan
  • How much will It cost? Off-the-shelf with modification vs custom development
  • Operational/deployment of Validated GxP medical cloud
  • Regulatory aspects: Technical filing (PMA/510k), FDA Title 21 CFR Part 12 Data – integrity, Post-Market Surveillance Plan (PMSP)
  • Intellectual property and flexibility in modification and implementation of new functionality
  • Cloud Service provider independence and data migration
  • Go to market plan; value for end-customers, value for distributors
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