Design Control

GPB provide support to establish effective medical device design and development controls to be defined, documented and implemented to demonstrate compliance with Quality System, Standards and regulations.

Design Control

We can assist with any aspect of Design Control including:

  • Intended Use

  • Human Factors and Usability to meet ISO/IEC 62366 and ANSI/AAMI HE75

  • Design Input / Output

  • Materials selection / biocompatibility

  • Design Verification & Review

  • Design Validation

  • Design History File (DHF)

  • Software Life-Cycle to meet IEC62304

  • Design Change Control

  • Design Transfer Control

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