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 Launches Communications Pilot to Accelerate High-Risk Medical Device Recall Notifications
The FDA’s CDRH has launched a pilot program to accelerate [...]
Adapting to FDA Shifts: How to Stay Ahead
The FDA plays a critical role in regulating medical devices, [...]
Navigating the Complexities of Combination Product Regulations and Patents
The combination products sector is an exciting intersection of drugs, [...]
Getting QMSR Ready: Key Changes and Steps to Prepare for the February 2026 Deadline
With the February 2, 2026 compliance deadline for the new [...]
Outsourcing with Confidence: A Guide to Successfully Hiring Specialty Expertise Consultants in Healthcare
Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term [...]
Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare
The healthcare landscape is constantly evolving, and with it, the [...]