Skip to main content

Literature & References

The CARE-IT Framework is not a regulatory standard and does not replace legal or statutory requirements.
However, it is positioned within the professional context of existing regulatory, normative, and methodological frameworks.

The references below provide the technical and conceptual background for governance, risk evaluation, lifecycle management, and operation of digital clinical infrastructure.

European Regulation​

Regulation (EU) 2017/745 – Medical Device Regulation (MDR)​

European regulation governing medical devices.

The MDR defines requirements for safety, performance, risk management, clinical evaluation, post-market surveillance, and responsibilities of manufacturers and operators.

CARE-IT particularly relates to:

  • Risk management obligations
  • Requirements for networked systems
  • Regulatory operator responsibility
  • Documentation and traceability requirements

MDCG Guidance Documents (Medical Device Coordination Group)​

Guidance documents supporting interpretation and implementation of the MDR.

Particularly relevant in the context of digital clinical infrastructure:

  • Guidance on Software as a Medical Device (SaMD)
  • Guidance on interconnected medical systems
  • Guidance on clinical evaluation and post-market surveillance
  • Cybersecurity guidance for medical devices

These documents clarify regulatory expectations regarding integration, interoperability, and system responsibility.

Swiss Regulation​

Medical Devices Ordinance (MedDO, SR 812.213)​

Swiss implementation of the European MDR regulatory framework.

The ordinance governs:

  • Market placement
  • Market surveillance
  • Obligations of economic operators
  • Documentation and safety requirements

CARE-IT is compatible with the regulatory requirements of MedDO but does not replace legal assessment.

Normative Foundations​

ISO 14971 – Medical devices — Application of risk management to medical devices​

International standard for risk management of medical devices.

Relevance for CARE-IT:

  • Systematic risk identification
  • Evaluation of clinical impact
  • Documented risk decisions
  • Consideration of residual risk

CARE-IT extends the product-focused logic of ISO 14971 to systemic and organizational interdependencies within clinical operations.

ISO/IEC 62304 – Medical device software — Software life cycle processes​

Standard defining lifecycle processes for medical device software.

Relation to CARE-IT:

  • Structured development and maintenance
  • Change management
  • Documentation
  • Version control

ISO/IEC 27001 – Information security management systems​

Standard for information security management systems.

CARE-IT incorporates information security requirements as part of patient-relevant risk evaluation but is not limited to IT security considerations.

Validation & Operation​

Computerized Systems Validation (CSV)​

Methodological framework for validating computerized systems, particularly in regulated environments.

Relevance:

  • Demonstration of functional suitability
  • Documented testing procedures
  • Change validation
  • Auditability

CARE-IT understands validation as part of structured operator responsibility.

GAMP 5 – Good Automated Manufacturing Practice​

Guideline for risk-based validation of computerized systems.

Particularly relevant in contexts involving:

  • Complex system constellations
  • Integration scenarios
  • Structured documentation requirements

Interoperability & System Constellations​

HL7 / FHIR Standards​

International standards for structuring and exchanging clinical data.

Relevance for CARE-IT:

  • Information integrity
  • Interface transparency
  • Cross-system consistency

Organizational & Governance Context​

ITIL (Information Technology Infrastructure Library)​

Framework for IT service management.

CARE-IT does not replace ITIL but extends its perspective by integrating clinical effectiveness, patient safety, and systemic care logic.

Positioning​

CARE-IT:

  • does not replace regulatory requirements,
  • does not certify organizations,
  • does not constitute an audit scheme.

It serves as a:

  • structuring reference framework,
  • governance model for healthcare operators,
  • organizational development instrument,
  • integration logic between clinical care and digital infrastructure.

Version Note​

References reflect the regulatory and normative context at the time of publication of CARE-IT Version 1.2.0.

Users are responsible for independently monitoring regulatory developments and updates.