Design & Development Control

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

With you we address & implement best practices:

  • Intended Use and Purpose

  • User requirements, clinical need, Human Factors and Usability Specifications 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

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