GDx: Regulatory Resources

eSTAR Template Walkthrough: Section-by-Section Guide for First-Time Filers

GrassrootsDX breaks down the eSTAR Template section by section for first-time 510(k) and De Novo filers. Read the full guide before you file.

Product Development

5 Ways to Catch Medical Device Software Defects Before They Become Costly Problems

Medical device software defects become more expensive the longer they go undetected. From design and risk analysis to testing, deployment, and post-market feedback, teams have opportunities throughout the product lifecycle to catch problems earlier. Here are five ways to shorten the gap between defect injection and detection—and reduce costly surprises later.

Top 5 FDA Cybersecurity Tips

5 tips to help ensure that your medical devices not only meet FDA approval standards but also remain secure against evolving cyber threats. By prioritizing cybersecurity throughout the device lifecycle, you can enhance patient safety, data privacy and regulatory compliance.

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