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 >>>
 ...

  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 >>>  

 

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 >>>