OBR+ builds on the ORCHA Baseline Review, extending assessment depth to support system-level adoption, regulated functionality, and advanced clinical risk environments.
Global
Enhanced assurance for higher-risk and regulated digital health technologies; the assessment behind our ORCHA Assured Silver scheme
Mapped to ISO 14971, IEC 62304, ISO 27001, DCB0129/DCB0160, NIST and more
Protecting personal data through lawful, transparent processing.
Governance, regulatory status, and proportionate evidence requirements.
Inclusive design, accessibility standards, and user-centred development.
Formal risk management, hazard logs, and Clinical Safety Officer requirements.
Structured information security management and cyber resilience.
Reliability, performance, update management and system robustness.
OBR+ is the enhanced version of the ORCHA Baseline Review. It expands the foundational OBR assessment to include deeper scrutiny across clinical safety, technical security, and system robustness.
While OBR establishes baseline compliance, OBR+ is designed for technologies operating in higher-risk contexts - such as clinical decision support, remote monitoring, treatment delivery, or regulated medical device environments.
The framework translates complex international standards into structured, objective micro-criteria; enabling fair comparison and proportionate assurance.
As digital health technologies become more complex, baseline compliance is no longer sufficient for system-wide adoption.
Health systems, insurers, and regulators increasingly require:
OBR+ provides the enhanced assurance required for procurement at scale. It bridges the gap between regulatory approval and operational deployment - creating confidence for governance teams, clinical leaders, and procurement decision-makers.
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OBR+ is the foundation of ORCHA Assured Silver; the enhanced certification tier for digital health technologies operating in higher-risk, regulated, or system-level environments.
Achieving OBR+ thresholds unlocks eligibility for ORCHA Assured Silver, providing a visible and trusted mark of enhanced compliance.
Once assessed, products are:
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