Own the Design History File (DHF) for software releases. Review artifacts for completeness and audit readiness...
assessments and quality trending CAPA input and support Design History File (DHF) audits NPD management reviews Provide...
with software (testing, quality assurance, test documentation and tools) and device (DMR, DHF, testing, and quality assurance...
and efficacy and are compliant to the highest standards. Perform DHF audits of other products as an independent reviewer...
62304, IEC 62366) is highly desirable. Demonstrated ability to review DHF documentation, evaluate design change impacts...
and documentation (GDP) Assists with generating, maintaining, and updating Design History Files (DHF) for new and/or existing products...
to implantation, such as long-term reliability and risk management. Participate actively in design reviews, Design History File (DHF...
with monitoring evolving compliance requirements and integrating updates into internal processes Support risk management files, DHF...
into internal processes Support risk management files, DHF updates, and design change documentation Contribute to EU MDR technical...
, establishing and maintaining the Design history file (DHF), ensuring compliance with all applicable regulations. The position... and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications. Manage deviation and issues...