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.
DecodeEU AI Act obligations
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 passing DTACThe five DTAC domains, the evidence assessors expect, and how to prepare without turning delivery into 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 more >Guide
A practical guide to passing DTAC
NHSThe five DTAC domains, the evidence assessors expect, and how to prepare without turning delivery into paperwork theatre.Read more >Briefing
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 more >Guide
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 more >Perspective
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 more >Report
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 more >Briefing
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 more >Perspective
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 more >Start here
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