{domain:"www.qualitydigest.com",server:"169.47.211.87"} Skip to main content

User account menu
Main navigation
  • Topics
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Videos/Webinars
    • All videos
    • Product Demos
    • Webinars
  • Advertise
    • Advertise
    • Submit B2B Press Release
    • Write for us
  • Metrology Hub
  • Training
  • Subscribe
  • Log in
Mobile Menu
  • Home
  • Topics
    • 3D Metrology-CMSC
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Login / Subscribe
  • More...
    • All Features
    • All News
    • All Videos
    • Contact
    • Training

Risk Management for Medical Devices

Gleaning best practices from regulatory standards

Adobe Stock

Wade Schroeder
Thu, 09/02/2021 - 12:02
  • Comment
  • RSS

Social Sharing block

  • Print
Body

As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers.

ADVERTISEMENT

Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort of cyber threat could have consequences for the integrity of the data and the privacy of the patient.

In fact, when building a connected device, it’s recommended to always assume your device will be the subject of some kind of cyber threat in order to mitigate such events from ever taking place. Regulatory bodies across the world have developed standards and requirements to guide medical device manufacturers with creating safe and secure connected devices.

In this article, we’re going to look at some key regulatory guidelines for medical device cybersecurity found in IEC 62304—“Medical device software—Software life cycle processes,” ISO 14971—“Medical devices—Application of risk management to medical devices,” and FDA guidance documents, which represent industry best practices and current manufacturing standards.

 …

Want to continue?
Log in or create a FREE account.
Enter your username or email address
Enter the password that accompanies your username.
By logging in you agree to receive communication from Quality Digest. Privacy Policy.
Create a FREE account
Forgot My Password

Add new comment

Image CAPTCHA
Enter the characters shown in the image.
Please login to comment.
      

© 2025 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute Inc.

footer
  • Home
  • Print QD: 1995-2008
  • Print QD: 2008-2009
  • Videos
  • Privacy Policy
  • Write for us
footer second menu
  • Subscribe to Quality Digest
  • About Us
  • Contact Us