list. Design Control – support the DHF/DCR creation, maintenance, and archival process;conduct DHF/DCR reviews/audits...
Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA...
PCB processes. In-depth knowledge of IEC 60601-1, ISO 13485, ISO 14971, and Class II regulatory pathways. Strong DHF/DMR...
Overview: The Dental Hygienist or Dental Hygiene Faculty (DHF), reporting to the Director of Dental Hygiene... discretion of the Director of Dental Hygiene, the DHF will also assist with student evaluations, counseling, and assessment...
engineering documentation including design inputs/outputs, test protocols, reports, risk analyses, and DHF elements. Support...
suppliers, test labs, and manufacturing partners. Ensure documentation, DMR, and DHF organization, traceability, and test...
documentation for the project Design History File (DHF). Collaborates on the development of inspection methods Initiates design...
, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...
, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...
Fundamental knowledge of Medical Device Design Control (DHF, EU MDR, CE Mark) Strong data analysis skills and experience (Minitab...