How FDA 510(k) Guidance affects
Medical Device Development

FDA 510(k) Guidance

Syringes, Catheters, X-Ray Machines, Medical Software (EMR) - All are considered Medical Devices by the FDA. All medical devices are affected by the FDA 510(k) Human Factors Regulations, some more than others. Managing Innovation meeting the 510(k) Human Factors Usability Requirements can be a daunting task. Product evaluation, product validation, Human Factors Engineering and User Experience testing are all part of the User Centered Participatory Design process. With R&D expenses escalating, it is beneficial to limit and minimize product risk by identifying product flaws as early in the process as possible.

HirLan specializes in User Centered Design and the evaluation process associated with innovative ideas, product features, and the final integration of innovation and User Centered Design. HirLan can help you meet the new FDA 510(k) Human Factors requirements through the:

  • Integration of the FDA 510(k) Human Factors Guidance into your product lifecycles
  • Application of the General Principles of Human Factors to your future Product lifecycles through User Centered Design concepts
  • Evaluation and Validation of your products against general Human Factors Principles
  • Manage the Risk Error with respect to basic human skills and abilities
  • Usability Testing and the appropriate methods to meet the FDA 510(k) Human Factors Guidance
  • Accessibility and Cross Cultural / Cross National Design concerns
  • User documentation, packaging and instructions for use