Insights That Move You Forward

Helping you make smarter decisions, avoid costly missteps, & bring safe, effective products to market with confidence

The Growing Role of Real-World Evidence in Regulatory Decisions
Regulatory Strategy, Clinical Research, Post-Market Surveillance, Real-World Evidence Crystal Norwood Regulatory Strategy, Clinical Research, Post-Market Surveillance, Real-World Evidence Crystal Norwood

The Growing Role of Real-World Evidence in Regulatory Decisions

Real-world evidence (RWE) is reshaping regulatory decisions, supplementing clinical trial data with insights from EHRs, registries, and digital tools. Regulators now rely on RWE to strengthen approvals and post-market surveillance. See how NMCG helps sponsors design data strategies that anticipate this evolving landscape. 

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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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