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.
![Medical Device- Design-Control-Image](https://www.gpb.co.uk/wp-content/uploads/2019/06/Design-Control-Image.jpg)
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
![Design Control GPB - Design Control](https://www.gpb.co.uk/wp-content/uploads/2018/02/Design-Control.png)