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What is considered to be a “trustworthy device”?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

The FDA recommends that manufacturers design devices that are trustworthy because they are more likely to meet their applicable statutory standard for premarket review and are more likely to remain safe and effective throughout their life cycle. Trustworthy devices:

  • Are reasonably secure from cybersecurity intrusion and misuse
  • Provide a reasonable level of availability, reliability, and correct operation
  • Are reasonably suited to performing their intended functions
  • Adhere to generally accepted security procedures.  

Documentation demonstrating the trustworthiness of a device will help FDA more quickly and efficiently assess the device’s safety and effectiveness with respect to cybersecurity.

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