Insights That Move You Forward
Helping you make smarter decisions, avoid costly missteps, & bring safe, effective products to market with confidence
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.
Real-World Impact: Poor Data Integrity Examples from Recent Rejections
Regulatory rejections often stem from preventable data integrity failures—like falsified lab results, poor traceability, or incomplete safety documentation. These errors delay patient access and damage credibility. Learn from real-world examples and see how NMCG helps sponsors safeguard submissions from costly pitfalls.
What to Expect from an FDA Pre-Submission Meeting
FDA Pre-Submission meetings offer critical insight into regulatory expectations before you invest time and budget. From strategy planning to meeting facilitation, NMCG helps sponsors maximize feedback, reduce delays, and approach FDA reviewers with confidence and clarity.
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.