PerspectiveWhat the EU AI Act means for medical AIHow high-risk classification interacts with medical device regulation, and the governance founders should build before assessment pressure arrives.Read perspective Insights
Field notes forregulated healthtechnology.
Practical, plain-English analysis of the rules shaping SaMD, AIaMD and health technology market access - written to help teams make better decisions earlier.
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SaMDAIaMDEU AI ActISONHSFDAMarket access
PerspectiveWhat the EU AI Act means for medical AIHow high-risk classification interacts with medical device regulation, and the governance founders should build before assessment pressure arrives.Read perspective 
GuideNHSA practical guide to DTAC V2 readinessWhat changed in DTAC V2, what still matters across the five assurance domains, and how to build buyer-ready evidence without paperwork theatre.Read more 
BriefingUS market510(k) vs De Novo: choosing your FDA pathwayHow to decide which route fits your device and how to avoid the detours that can cost a young company months.Read more 
GuideQualityISO 13485 for software-only companiesHow to build a lean, audit-ready quality system when your product, evidence and release cycle are entirely software-led.Read more Latest thinking
Regulation, translated into decisions founders can act on.
The insight library will grow into a practical knowledge base for SaMD, AIaMD, management systems and global market access.
Perspective
What the EU AI Act means for medical AI
EU AI ActHow high-risk classification interacts with medical device regulation, and the governance founders should build before assessment pressure arrives.Read moreGuide
A practical guide to DTAC V2 readiness
NHSWhat changed in DTAC V2, what still matters across the five assurance domains, and how to build buyer-ready evidence without paperwork theatre.Read moreBriefing
510(k) vs De Novo: choosing your FDA pathway
US marketHow to decide which route fits your device and how to avoid the detours that can cost a young company months.Read moreGuide
ISO 13485 for software-only companies
QualityHow to build a lean, audit-ready quality system when your product, evidence and release cycle are entirely software-led.Read morePerspective
DCB 0129 explained for manufacturers
Clinical safetyWhat clinical risk management involves, who needs a Clinical Safety Officer, and how to connect safety evidence to product decisions.Read moreReport
One technical file, six markets
ExpansionHow to structure claims, risk, software and clinical evidence so entering Canada, Australia and Brazil reuses what you have already built.Read moreBriefing
ISO 42001 as a trust signal for health AI
AI assuranceWhy an AI management system can become more than certification work when buyers need proof of oversight and accountability.Read morePerspective
Regulatory capability without the corporate machine
Founder playbookA practical operating model for startups that need serious compliance thinking before they can justify a large internal team.Read moreStart here
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