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.
Does Your Existing Combination Product Need Design History Files?
Combination products are defined by the U.S. Food and Drug [...]
Is Your Product Truly a Combination Product?
The last three decades have seen vast growth in the [...]
Effective Change Management in Medical Device Manufacturing
Change is an inherent part of the lifecycle of a [...]
Cyber Risk in the Life Sciences Industry
The life sciences industry is particularly vulnerable to cybercrime, given [...]
The Facts About Medical Device Tax
The Medical Device Tax has been a divisive issue since [...]
Medical Device Manufacturers: Is Now the Right Time to Launch a Transformation Initiative?
As a medical device manufacturer, you need growth and margins [...]