Medical Device Risk Management

Risk Management Saves Time & Money

We can help you meet FDA and EU risk management requirements and follow an industry-recognized software development lifecycle (SDLC).

  • Compliant with the ISO 14971, IEC 60601, and IEC 62304
  • Follow an industry-recognized software development lifecycle (SDLC)
  • Manage risk in every medical device lifecycle
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Medical Device Risk Management Best Practices

Risk Evaluation

We’ll help evaluate the risk profile of your device/project.

Risk Mitigation

We can help you develop and implement a remediation plan to mitigate as much risk as possible.

Residual Risk Analysis

We’ll continually circle back to ensure that your risk management needs and responsibilities are being met.

Resources

March 29, 2021

What Is Polarion?

Learn more about our tool that streamlines product development in a compliance-based...
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July 5, 2022

Change Management in the Medical Device Industry

Change management means different things to different people depending on the industry they work in. Thinking about it broadly, change management is the ability to track changes and implement...
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February 17, 2022

Medical Device Design Control with Siemens PLM Software

Medical device product development is a highly integrated and regulated process. Implementation of a requirements tracking solution requires...
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    Dan Sterling Photo of Dan Sterling President
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 dan@sterlingmedicaldevices.com
    John Campbell Photo of John Campbell VP of Operations
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jc@sterlingplm.com
    John Fargo Photo of DanJohn Fargo PLM Manager
    250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
    201-227-7569 jf@sterlingplm.com