IVDR 2017 746. In Vitro Diagnostics Device Regulation

Information & Training.

Medical Device:

• • • Validation. Classification. Regulation. Requirements. Current best practices.
    • FDA cGMP’s. EU MDR’s / MDD’s.
    • FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
    • FDA Medical Device Classification. The FDA approach to Medical Device Classification.
    • EU Medical Device Regulation and Classification (per MDD’s).
    • ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
    • Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
    • Quality System requirements to maintain compliant Validations.
    • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
    • Medical Device Software Validation.
    • Medical Device Design Validation.
    • Electronic Signature, Electronic Records.
    • Life Cycle Approach to Validation.
    • Risk Identification. Documentation. DHR’s. DMR’s.
    • Etc. Etc. …
    • Information & Training presentation >>>