, and Design History File (DHF) completeness. Lead and support risk management activities per ISO 14971 using a system-level, top...
and ensure compliance with IEC 62304/82304. Support supplier qualification, design transfer, and DHF completeness. Contribute...
, risk controls, verification, and validation. Support design reviews, phase gate readiness, and Design History File (DHF...
verification and DHF deliverables Build and maintain Product Specification Files (PSF) for company program... development project before as QA Signed off on design development plan, completed design verification, approved DHF deliverables...
risks. Ensure all control measures feed directly into the Risk Management File and the Design History File (DHF...
and DHF documentation. Perform hardware/software/lab tests;Ensure compliance with ISO 13485 standards. Communicate status... and execute V&V Plans, Protocols, and Reports. Maintain requirements traceability and DHF documentation. Perform hardware...
, risk controls, verification, and validation. Support design reviews, phase gate readiness, and Design History File (DHF...
and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical...
BECS program. Review Donor History Forms (DHF) for completeness;evaluates donors medical history for suitability.... Performs confidential interview with donors;instructs the donor regarding the Interview Response Section (IRS) of the DHF...
, and reliability requirements are met. Owns and drives design control documentation, including DHF elements (design inputs, outputs...