Verification and Validation of Cell Expansion Medical Device

Ensured regulatory compliance of Cell Expansion medical device.


Software V&V Medical Devices New Product Development

Ensured that Cell Expansion medical device and its manufacturing process met its design input requirements and conformed to defined user needs and intended uses and are compliant with QSR 21 CFR. Implemented a robust and cost-effective medical device verification and validation program. Wrote effective verification and validation plans, protocols and final results reports. Designed and executed manual and automated test cases.

Accomplishments

  • Participated in requirements gathering, analysis, system design, detailed design, testing, project management, and compliance.
  • Designed and executed manual test plans and automated test cases.
  • Ensured requirements traceability.
  • Participated in design and process FMEA by identifying and quantifying any potential hazards during the design and development process.
  • Mitigated risks to a acceptable level and affirmed the acceptability of risk prior to marketing the cell expansion.

Client

TerumoBCT