Regulatory Guidance, Compliance Strategies, and Expert Insights for Regulated Industries
Navigating the complexities of FDA regulations, ISO standards, and evolving compliance frameworks requires more than just awareness — it demands expertise, insight, and reliable guidance. At Quality Solutions Now, our News and Advice hub delivers authoritative content designed to help medical device manufacturers, pharmaceutical firms, biotech companies, and combination product developers stay informed and proactive. From project management best practices to risk mitigation strategies, our articles and resources reflect the depth of experience behind our proprietary qsnFLOW™ methodology. Whether you’re preparing for an audit, launching a new product, or optimizing your quality systems, this is your trusted source for actionable, industry-specific knowledge that helps you reduce risk, ensure compliance, and drive operational excellence.
FDA’s New Draft Guidance on Form 483 Responses: A 15-Business-Day Quality Playbook
FDA recently issued a draft guidance: “Responding to FDA Form [...]
FDA’s “One Pivotal Trial” Default: What It Means for Evidence Quality, Not Just Speed
On February 18, 2026, FDA leadership signaled a major shift [...]
QMSR is Live: A Practical Readiness Checklist for Device Manufacturers
On February 2, 2026, FDA’s revised 21 CFR Part 820 [...]
Inside FDA’s “TEMPO” Pilot
FDA closed out 2025 - and opened the door to [...]
The Top 3 Risk Management Failures FDA Continues to Cite
Across medical device and IVD inspections, U.S. Food and Drug [...]
FDA Finalizes Real-World Evidence Guidance for Medical Devices: What It Means (and How to Use It)
FDA closed out 2025 with a meaningful update for device [...]







