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The FDA’s QMSR Is Now in Effect
Regulatory Strategy, Quality Systems, FDA Compliance, Risk Management, Medical Device Development Crystal Norwood Regulatory Strategy, Quality Systems, FDA Compliance, Risk Management, Medical Device Development Crystal Norwood

The FDA’s QMSR Is Now in Effect

The FDA’s Quality Management System Regulation (QMSR) is now in effect, aligning U.S. medical device quality requirements with ISO 13485. Learn what’s changed, how FDA inspections are evolving, and how manufacturers can implement defensible risk management approaches—without being locked into ISO 14971.

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The Sales Trap That’s Costing You Clients
Regulatory Strategy, Industry Commentary, Podcast Features, Business & Growth, Consulting & Advisory, Client Relationships, Clinical & Quality Integration Crystal Norwood Regulatory Strategy, Industry Commentary, Podcast Features, Business & Growth, Consulting & Advisory, Client Relationships, Clinical & Quality Integration Crystal Norwood

The Sales Trap That’s Costing You Clients

In this Q&A recap of The Business of Learning Podcast, NMCG President & Principal Consultant Michael Nilo joins host João Camargo to unpack the “sales trap” that costs expert service providers clients: stopping at “you can’t do that” instead of mapping what is possible. Learn how NMCG blends regulatory rigor with practical, business-savvy guidance for medtech innovators.

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Navigating the FDA During a Government Shutdown
Regulatory Strategy, FDA Insights, Risk Mitigation, Industry Commentary, Podcast Features Crystal Norwood Regulatory Strategy, FDA Insights, Risk Mitigation, Industry Commentary, Podcast Features Crystal Norwood

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.

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