Standalone MDSW or SaMD
Applications that perform their medical purpose without being part of a physical medical device.
Diagnostic · monitoring · decision supportMedical software
Turn a software product into a defined medical device
Medical software can diagnose, monitor, predict, recommend or control. Its route to market begins with a precise intended purpose and a defensible boundary between the product, its platform and the wider care environment.
Product definitionRegulatory starting point
Medical
software
software
Clinical function
Intended user
Patient impact
Use environment
EU MDR or IVDR US FDA pathway
Product landscape
Medical software takes different product forms
The architecture may change, but the regulatory question remains product-specific. What does the software do, for whom, and how can its output affect diagnosis, treatment or patient management?
Embedded and controlling software
Software or firmware that drives, controls or influences the operation of a physical device.
Control · automation · safety functionsPlatform-based products
Medical functions delivered through mobile, cloud or connected-care environments with shared components.
Apps · cloud · remote careIVD and analytical software
Software that analyses laboratory or specimen-derived data and provides medically relevant information.
Interpretation · algorithms · workflowsRegulatory route
The pathway follows the clinical role, not the technology label
The same technical function can fall outside medical-device regulation, qualify as MDSW under the MDR, become IVD software under the IVDR, or follow an FDA device pathway in the United States. Intended purpose, the significance of the information and the healthcare decision involved determine the route.
Start hereIntended purpose and claims
01QualificationIs the function medical?
02ClassificationWhat is the potential impact?
03EvidenceWhat must performance prove?
EUMDR or IVDR
USFDA pathway
Lifecycle priorities
Evidence must develop with the software
Regulatory work is strongest when it is integrated into development. The product definition, risks, requirements, testing and clinical evidence should remain traceable as software versions and connected components change.
Software lifecycle
IEC 62304 planning, architecture, requirements, configuration, problem resolution and release evidence.
Safety and human use
ISO 14971 risk management, usability engineering, clinical workflows and foreseeable misuse.
Security and connectivity
Cybersecurity, data flows, interfaces, third-party components, cloud services and update mechanisms.
Performance and change
Verification, validation, clinical evidence, post-market monitoring and regulatory assessment of modifications.
MDRC support
One regulatory direction across the complete software product
We support qualification and classification, EU and US regulatory strategy, IEC 62304 lifecycle compliance, risk management, cybersecurity, usability, clinical or performance evaluation, technical documentation, quality systems and post-market compliance.
Engagement can begin with an early concept, a product already in development or an existing technical file that needs a coherent route to submission.
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