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

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