The Qualio Blog
Insights on product development, quality management, and regulatory compliance for teams building life-saving products.
ISO 14971 in the Age of AI: What ISO/TS 24971-2:2026 Adds
ISO/TS 24971-2:2026 guides ML risk management under ISO 14971. See what the new companion standard covers, and what it means for your risk file.
Sumatha Kondabolu
What the FDA's AI Device Software Guidance Signals for Your Traceability
FDA's draft AI-enabled device guidance demands dataset provenance and post-market monitoring across the TPLC. See what it means for your traceability now.
From Algorithm to Aisle: What Naritas CEO Nora Keldy Teaches Us About Building AI-Native Life Sciences Companies
From algorithm to aisle: Naritas CEO Nora Keldy on why AI-native biotech companies can't separate scientific ambition from quality infrastructure — and what that means for how you build.
Why the FSP Model Is Having Its Moment (and What It Means for Clinical Trial Operations)
Why are more biopharma sponsors turning to functional service providers? Dr. Les Enterline of PPD breaks down the FSP model, the rise of mixed-model outsourcing, and what it really takes to flex clinical trial resources without sacrificing quality or control.
Why healthcare is the last industry to go digital -- and what's finally changing
Healthcare has resisted digital transformation longer than any other industry. Four-time entrepreneur Mariano Valenio breaks down why -- and what AI, data, and continuous compliance are finally changing.
Why Context Is the Real Competitive Advantage in Life Sciences
RCG Intel founder Joe Luminello on why context beats data, how to think deliberately about AI adoption, and what's creating paralysis for pharma and biotech companies right now.
Championing Women in STEM: What Noreen Hong's 28-Year Career at Thermo Fisher Teaches Us About Growth, Leadership, and the Future of Life Sciences
Noreen Hong, VP and General Manager at Thermo Fisher Scientific, shares 28 years of career lessons on leadership, sustainability, AI in the lab, and championing women in life sciences.
If Compliance Is Slowing You Down, Your Regulations Are Not the Problem. Your Model Is.
The medical device industry has accepted a false tradeoff. Here's how the best MedTech companies are rejecting it.
Why Hiring More QA Staff Won't Solve Your Biotech Compliance Capacity Problem
Hiring more QA staff doesn't solve biotech compliance capacity problems — it masks them. Learn why compliance complexity outpaces headcount, and what a continuous compliance execution model actually looks like.
6 Signs You're Going to Break at IND: And Don't Know It Yet
Pre-IND biotech teams often mistake a clean GLP audit for clinical readiness. These six structural warning signs reveal whether your quality system is built for clinical demands or running on heroics before IND exposes the gap.