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 Opens the Door on GenAI-Enabled Medical Devices: Why Quality Systems Need to Be Ready
On August 18, 2026, FDA issued a discussion paper seeking [...]
eMDR Changes Are Coming: Why Postmarket Reporting Needs a System Readiness Check
FDA has been updating its eMDR System Enhancements page to [...]
FDA’s TAP Pilot Expansion: Why Early FDA Engagement Requires Quality Readiness
FDA’s Total Product Life Cycle Advisory Program (TAP) continues to [...]
FDA’s Proposed Registration Rule: What Distributed Manufacturing Means for Quality Oversight
On July 10, 2026, FDA issued a proposed rule that [...]
FDA PreCheck and the New Facility Readiness Mindset
On June 29, 2026, FDA announced the selection of seven [...]
Human Factors Is Submission Strategy: What FDA’s Final Guidance Means for Device Teams
On May 29, 2026, FDA issued its final guidance, “Content [...]







