Planning Your 2027 Audit Program: What to Have Ready and When (Plus a Free Workbook!)
Our guide to annual audit planning, an open invitation to get your program resourced now, and an Excel workbook you can use to put your plan together.
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Trump Nominates Heidi Overton for FDA Commissioner
What we know so far, and what it may signal about the agency's direction.
Managing AI Risk Across Global Quality Systems with Julio Salwen
MiniMed's Chief Quality Officer on why compliance should be a byproduct, not the goal, what "know enough to be dangerous" actually means, and why you might be on an escalator going the wrong way.
Managing AI Risk Across Global Quality Systems
How do you manage AI risk across global quality systems while the tools change every week?
Ask Us Anything About AICA
We're recording an in-depth AICA session soon. Submit a question and we'll take it on during the demo!
The Case for Engaging Regulatory Early with Leland Keyt
Most companies bring regulatory in when they're ready to submit. A 20-year MedTech regulatory leader on why that's already too late, and what it costs.
The Case for Engaging Regulatory Early
Most companies bring in regulatory expertise when they're ready to file.
RA/QA News Roll: Late July 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Why Quality and R&D Default to Conflict (and How to Fix It)
A former VP of Quality on the learned behavior behind the roadblock stereotype, why Quality usually gets the last timeline, and what it takes to be a strategic advisor instead of a gatekeeper.
Why Quality and R&D Default to Conflict (and How to Fix It)
Why do quality and R&D fall into adversarial roles even when both are working toward patient safety?
A Warning Letter Citation AICA Likely Would Have Flagged
A quick look at how AICA might have caught the indicators of a real FDA warning letter citation in its reports.