Responsible for Design Validation Plan, Design Validation Protocols and Design Validation Report. Defines the entry and exit criteria for Design Validation.
To organize and perform internal and external validation activities, to validate the clinical satisfaction and acceptability of product and function under clinical circumstances.
To establish and maintain good relationships with clinical experts, hospitals and governments according to PDLM and project requirements, therefore, to co-ordinate site visits, obtain clinical data and information and organize expert visits.
To join risk analysis for clinical feedback according to Risk Evaluation process.
Has overall responsibility for the design validation function and outputs, overall planning, coordination and tracking of the Design Validation activities and act as SME during internal and external Audits.
Responsible for Design Validation Traceability Matrix, generating and providing validation evidence for different regulatory bodies (FDA, NMPA, CE, etc.) as per the company QMS process.
Has ability to participate in image review and can give observation/feedback independently
Translate issues reported from the clinical sites into defects. Submit defects in the defect management tool.
Provides the training and guidance for the design validation’s clinical sites，Collects Design Validation Records and feedback from the clinical site and ensures they both adhere to good documentation practices.
