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How a Government Shutdown Affects FDA Medical Device Regulation
Regulatory Strategy, FDA Submissions, Medical Device Submissions, Policy & Compliance Michael Nilo Regulatory Strategy, FDA Submissions, Medical Device Submissions, Policy & Compliance Michael Nilo

How a Government Shutdown Affects FDA Medical Device Regulation

Government shutdowns don’t completely stop the FDA—but they do create unpredictability. While essential functions like recalls and safety monitoring continue, new submissions, inspections, and policy development often stall. Learn what history tells us about shutdown impacts and how device makers can prepare.

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How the FDA Prioritizes Cybersecurity in Device Submissions
Regulatory Strategy, Medical Device Submissions, Cybersecurity & Compliance, Product Development Crystal Norwood Regulatory Strategy, Medical Device Submissions, Cybersecurity & Compliance, Product Development Crystal Norwood

How the FDA Prioritizes Cybersecurity in Device Submissions

Cybersecurity is now inseparable from patient safety. The FDA views it as a critical factor in determining whether a medical device is safe and effective for market approval. Learn how the agency prioritizes cybersecurity in submissions—and what steps sponsors must take to avoid delays, protect patients, and build regulator-ready strategies.

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