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.
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 [...]
QMSR Technical Amendments Finalized: What Medical Device Companies Should Know Before February 2, 2026
With the February 2, 2026, implementation date for FDA’s Quality [...]
What Regulators Are Really Worried About Going into 2026 (and What Your QMS Should Do Next)
If you want to know where regulatory expectations are headed, [...]
After the Shutdown Ends — What’s Next for FDA and Industry Timelines?
The U.S. government shutdown has finally ended, and for the [...]







