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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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Professional on computer reviewing ISO documents.

October 18, 2023

What’s New in ISO 10993-17:2023?

In early September, the International Organization for Standardization (ISO) released new ISO standards for medical devices: the ISO 10993-17:2023 (en) Biological Evaluation of Medical...

Requirements Management and Cybersecurity Webinar

Do you struggle with managing requirements for your products? Are you concerned about cybersecurity and the potential impact of software...