ISO 14971:2020 Risk Management for In Vitro Diagnostic (IVD) Medical Devices

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01

Course description

A course dedicated to the specific application of ISO 14971:2020 and ISO/TR 24971:2020 to in vitro diagnostic (IVD) medical devices, considering the technical and regulatory characteristics of this product category, including analytical and clinical performance and the risk of incorrect results.

02

Course objective

Enable participants to manage IVD product risk, considering analytical, pre-analytical and clinical characteristics, and meeting ANVISA, FDA (CDRH/OIR) and European IVDR requirements.

03

Course programme

24h of in-depth learning
  1. 01

    Risk characteristics specific to IVDs

  2. 02

    Analytical, clinical and use-related risks

  3. 03

    Risk of false-positive and false-negative results

  4. 04

    Performance and integrated risk management

  5. 05

    Relationship with ISO 13485 and RDC 665/2022

  6. 06

    Risk Management File applied to IVD

  7. 07

    ANVISA, FDA and IVDR 746/2017 expectations

04

Who can attend?

  • IVD R&D and Quality professionals, Regulatory Affairs professionals, clinical scientists, engineers and consultants working in in vitro diagnostics.