Medical Device
Frames AI-assisted device-development work around FDA SaMD, ISO 13485, HIPAA, and GDPR Article 9 considerations, with PHI redaction, source checks, quality scoring, a configurable human-oversight point, and recorded outcomes.
This template is a configurable starting point and control mapping. It is not certification, legal advice, or a guarantee of compliance; validate it against your obligations and environment before use.
US, EU, Global
4 references
5 mapped domains
Regulated SaaS, Clinical Zero-Retention
Referenced Frameworks, Standards & Obligations
Mapped Control Domains
Deployment profiles
Get started in 3 steps
Open the template
Open the catalog entry in the Keeptrusts console and review its included controls, references, and deployment metadata.
Adapt the configuration
Use the template as a starting point, then adjust relevant policies, thresholds, routing, and review settings for your requirements.
Validate before rollout
Test every outcome you configure—such as allow, redact, block, or operator review—before deploying through a supported gateway workflow.
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