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Quality Systems in the Spotlight: 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

Quality Systems in the Spotlight: 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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CRO vs. Consulting Firm: What’s the Difference and Why It Matters
Clinical Research, Regulatory Strategy, Medical Device Development, CRO Services, Consulting & Advisory Crystal Norwood Clinical Research, Regulatory Strategy, Medical Device Development, CRO Services, Consulting & Advisory Crystal Norwood

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.

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