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 systems, 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

  • Standard Operating Procedures
  • QMS Standards
  • Regulatory Requirements
  • Intended Use and Clinical Claims
  • Design & Development Planning
  • Usability Specification
  • Risk Management Planning
  • Functionality
  • Software Lifecycle
  • Materials Selection
  • Biocompatibility
  • Labelling and UDI
  • Packaging
  • Safety Testing
  • Stability, Sterility and Shelf Life
  • Bench Studies
  • Design Review and Verification
  • Bill of Materials (BOM)
  • Performance and Safety Studies
  • Design / Software Validation
  • Design Release
  • Technical Documentation
  • Design History File (DHF)
  • Design Transfer / Design Change
  • UDI

Would you like to know more?

We are here to help  you with any enquiries you may have, if you would like to speak to a member of staff, please fill out the following contact form or feel free to contact us on one of the following: