Insights That Move You Forward
Helping you make smarter decisions, avoid costly missteps, & bring safe, effective products to market with confidence
MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown
When the U.S. government shuts down, FDA operations slow—and medical device companies can face costly delays. In this Global Medical Device Podcast Q&A, NMCG President and former FDA Scientific Reviewer Michael Nilo explains what continues, what stops, and how MedTech leaders can strategically navigate the disruption.
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 Does “Regulatory-Ready” Data Look Like?
Not all data meets regulatory standards. Regulatory-ready data is accurate, contextual, globally aligned, and organized for review. NMCG helps clients capture and present data that accelerates approvals, reduces rework, and builds reviewer confidence from day one.
3 Signs Your CRO Strategy Needs Adjustment
Missed timelines, poor data quality, and communication gaps are red flags that your CRO strategy isn’t working. NMCG provides the oversight, project management, and flexibility needed to keep clinical trials compliant, efficient, and on track.
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.
Common Protocol Pitfalls and How We Help You Avoid Them
Clinical trial protocols often fail when they’re overly complex, misaligned with regulatory expectations, or impractical for sites and study subjects. These pitfalls cause delays, costly amendments, and wasted resources. NMCG helps sponsors avoid common missteps by designing clear, compliant, and right-sized protocols built for success from the start.
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.
CRO vs. Consulting Firm: What’s the Difference and Why It Matters
Success in clinical development depends on knowing when to engage a CRO and when to rely on a consulting firm. CROs excel at executing trials with precision, while consulting firms guide strategy, submissions, and compliance. Understanding the difference—and when you need both—can mean the difference between costly delays and streamlined market approval.