By the Standards

Addressing Risk Management and Usability in Medical Device Development


At Cognition, we believe in a risk-first approach to medical device risk management. Beginning at the early stages of product planning and development, risk management and usability testing play vital roles in the overall success of a product. Therefore, both of these topics have importance in the design process. Our paper, By the Standards: Risk Management and Usability in Medical Device Development, provides an overview of regulations and standards relevant to risk management and usability as well as best practices and processes for implementing in design control or as part of general safety and performance requirements.

Inside you will find:

  • Why Early Integration is Key
  • Applicable FDA Standards
  • 483 Observations
  • Risk Management Techniques
  • Usability and Human Factors

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