In-depth guides for compliance teams & founders.
Practical analysis on medical device regulatory strategy, ISO 13485, FDA QMSR, and information security — written for the people who actually have to implement them.
How to select and qualify a contract manufacturer for your medical device.
The non-negotiable requirements, the qualification process most founders skip, why cost should be the last conversation, and the component problems that stop production cold.
Read the guide →IEC 62304 for machine learning: mapping software lifecycle to ML development.
How to map IEC 62304 software lifecycle requirements to machine learning development — the mental model, architecture decomposition, probabilistic verification, configuration management, and the retraining question.
Read the guide →The ISO 13485 internal audit checklist for medical device startups (2026).
Organized by audit reality, not clause number — what auditors examine first, the company basics nobody prepares, where startups specifically fail, and the gotchas that catch even experienced teams off guard.
Read the guide →From prototype to 510(k): a practitioner’s guide to AI SaMD submission.
The complete guide to taking an AI/ML medical device from working prototype to FDA clearance — team, QMS, Pre-Sub strategy, AI documentation, cybersecurity, clinical evidence, and submission preparation. Phase by phase, with a visual timeline.
Read the guide →How to find the right compliance consultant for your medical device startup: the PACE framework.
Partnership, Alignment, Credentials, Experience — a practical framework for evaluating medical device compliance consultants, including the compliance hierarchy, common mistakes, and 10 questions to ask in a scoping call.
Read the guide →Build to sell, or build to run: a strategic choice for medical device founders.
The single most consequential strategic decision a medical device founder makes — and the one most founders make by default. How the choice cascades through QMS architecture, headcount, capital, and risk. With a side-by-side comparison.
Read the guide →Don’t start with the 510(k): a founder’s guide to medical device regulatory strategy.
Most medical device startups burn $200,000 and 18–26 months on the wrong FDA pathway — when a smarter strategy could have launched them in 8 months for $10,000. With a real 513(g) case study.
Read the guide →