QbD: Design & Development Control

Effective, compliant design & development controls using Quality by Design (QbD) principles that:

  • encompass the complete device life cycle;
  • demonstrate medical device safety, performance & usability;
  • embrace international  / national technical standards and regulations.

With you we address state of the art & implement best design & development practices:

  • Intended Use and Purpose

  • User requirements, clinical need, Human Factors and Usability Specifications to meet ISO/IEC 62366 and ANSI/AAMI HE75

  • Design, Development & Risk Management plans

  • Materials selection and Testing e.g. mechanical, electrical & biocompatibility

  • Design verification planning, safety & performance testing

  • Design Verification & Validation to ensure manufacture / process definition and Clinical Evaluation

  • Design History File (DHF) collation

  • Built in or Stand Alone Software design & Life-Cycle to meet IEC 62304

  • Design Change Control & re-validation

  • Design Transfer to enable manufacture / assembly with defined product and process specifications

  • 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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