Product managers & owners
Product intent, clinical value, prioritisation and decision-making within a regulated development system.
Guide details →1 PDF · 23 August 2026
Executives & commercial leaders
Decisions, exposure, resources, readiness and business consequences.
Downloadable field guides
Guidance written for your role
Quality & regulatory teams
Two complementary guides covering quality assurance, regulatory strategy, evidence, submissions and lifecycle governance.
Guide details →2 PDFs · 23 August 2026
Risk managers
ISO 14971-centred risk management connected to engineering decisions, evidence and lifecycle governance.
Guide details →1 PDF · 23 August 2026
C-Suite & leadership
Executive decisions, governance, resources, exposure and evidence across a regulated product lifecycle.
Guide details →1 PDF · 23 August 2026
Articles
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Connected medical devices: securing the whole ecosystem
How dependencies, trust boundaries and compromised networks should shape threat modelling and penetration testing for connected medical devices.
When medical software fails quietly
How stale data, incorrect units, patient mismatches and misleading displays can produce plausible but wrong outputs—and how to detect and control these quiet failures.
The algorithm is not the product
Why successful medical software requires evidence for the complete clinical product and workflow—not only the performance of its algorithm.
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The practical guide to developing a medical device
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