Design Control

Engaging with you to establish compliant effective design and development controls that demonstrate medical device safety, performance, usability in accordance with ISO 13485, CFR 820,  international technical standards and regulations.

Design Control

With you we address & implement good practice:

  • Intended Use and Purpose

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

  • Design and Development plans

  • Materials selection and Testing e.g. physical & biocompatibility

  • Design verification planning, safety & performance testing

  • Design Validation to meet including Clinical Evaluation

  • Design History File (DHF) collation

  • Software design & Life-Cycle to meet IEC 62304

  • Design Change Control & re-validation

  • Design Transfer  Control to manufacture

  • Standard Operating Procedures
  • QMS Standards
  • Regulatory Requirements
  • Intended Use and Clinical Claims
  • Design & Development Planning
  • DFMEA
  • 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

More Information?

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