Thinking Through AI

Clinical AI Model Validation for product leads: staged testing, subgroup bias checks, TRIPOD+AI reporting, GMLP and post-launch monitoring.

The full journey from AI strategy to scaled implementation in four stages: align and assess, choose and plan, prove and build, govern and scale.

How HealthTech companies meet security and compliance expectations: HIPAA safeguards, business associate agreements, safe data handling, and SOC 2 or HITRUST.

How medical device software is regulated in the US and EU: device status, classification, routes to market, the engineering standards and what changes for AI.

Ambient Clinical Documentation EHR Integration: write-back options, SMART scopes, consent rules and quality checks for teams building AI scribes.

ISO 13485 design controls for software teams: clause 7.3 stages, traceability, agile sprint mapping, tools and the FDA QMSR.

EU MDR Rule 11 explained: how Annex VIII classifies medical device software as Class I, IIa, IIb or III, with MDCG 2019-11 Rev.1 guidance.

SaMD classification FDA explained: IMDRF risk categories, FDA device classes, 510(k), De Novo and PMA routes, and CDS exclusions for healthtech teams.

IEC 62304 software safety classification explained: how Class A, B and C are assigned, what each class requires, and what Edition 2 changes.