Design Control
Establishing effective, efficient design & development processes and controls from planning to design validation and transfer. Applying QFD and QbD principles to meet user/patient needs and demonstrating compliance with medical device Quality Systems, ISO / National Standards and country regulations.
Improving all aspects of Design Control including:
Intended Use / Purpose
Human Factors and Usability to meet ISO/IEC 62366 and ANSI/AAMI HE75
Design Input Requirements / Output
Materials selection / biocompatibility
Design Verification, Testing & Review
Design Validation to evidence safety and performance
Design History File (DHF) compilation
Software Life-Cycle to meet IEC62304
Design Change Control and Approval
Design Transfer to Manufacture
