MDR 2017 745 Timeline. Medical Device Regulation Implementation.

Information & Training. | Medical Devices.

Note: Latest update: The EU MDR’s “Date of Application” has currently been extended for one year, from 26th May 2020 to 26th May 2021 due to the impact of Covid 19.

MDR 2017 745 Timeline. EU Medical Device Regulation.

MDR Medical Device Regulation EU 2017 745 Timeline. Information and Training presentation on Medical Device Regulation, Validation, Classification, …

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 >>>