Insights
Regulatory & quality guides
Practical, plain-language guidance on getting medical devices cleared and to market.
2026-06-17
510(k) vs. De Novo: Which FDA Pathway Fits Your Device?
How to choose between an FDA 510(k) and a De Novo request: when a predicate exists, how risk classification drives the decision, timelines, and what each pathway requires.
2026-06-16
Do You Need an FDA US Agent?
What an FDA US Agent is, which foreign medical-device manufacturers are required to have one, what the agent actually does, and how it differs from an Official Correspondent and an Initial Importer.
2026-06-15
EU MDR vs. MDSAP: What's the Difference?
EU MDR and MDSAP are often confused. One governs market access in Europe; the other is a single quality-system audit recognized across multiple countries. Here's how they fit together.
2026-06-14
Medical Device Cybersecurity & the FDA
Cybersecurity is now a gating requirement for FDA clearance of connected devices. What 'cyber device' means under section 524B, the SBOM requirement, and what FDA expects pre- and post-market.
2026-06-13
AI as a Medical Device (SaMD): The FDA Path
How FDA regulates AI/ML-based Software as a Medical Device: classification and pathway, Good Machine Learning Practice, and the Predetermined Change Control Plan that lets you update models post-clearance.
2026-06-12
ISO 13485 for Medical Device Startups
Why early-stage medical-device companies need an ISO 13485 quality management system, what it requires, how it ties to FDA's QMSR, and a phased way to build it without slowing the team down.
2026-06-11
Building Production AI: Lessons from Shipping Real Products
What it actually takes to ship AI products that run in production, not demos: evaluation, guardrails, cloud-native architecture, cost control, and treating the model as one component of a real system.
2026-06-10
How to Author an FDA 510(k): A Practical Guide
What a 510(k) submission is, when you need one, the sections FDA expects, the eSTAR requirement, review timelines, and the mistakes that trigger delays.