Build Compliant Medical Software, Faster

By integrating and distributing Posos solutions already CE marked, you become a Distributor under EU MDR 2017/745 (Article 14). As a Distributor, your regulatory obligations are significantly lighter than those of a Manufacturer: you verify that the CE marking is in place, ensure proper storage and transport conditions, and forward any incident reports to the Manufacturer, but you do not need to manage the conformity assessment process for the Posos components.

If your complete software product independently qualifies as a medical device, you will need your own CE marking. However, by integrating Posos, your entire prescription analysis module is already covered: drug-drug interactions, drug-disease interactions, dosage control, treatment suggestions, and therapeutic alternatives. This significantly reduces the scope of your own conformity assessment to the parts of your product outside of prescription analysis.

The CE marking covers our APIs for:
  - Drug-drug interaction detection
  - Drug-disease interaction detection
  - Dosage analysis (overdose, underdose, duration)
  - Treatment and dosage suggestions
  - Therapeutic alternative recommendations

Medication search, editing, and database browsing functions are not medical devices.

Posos maintains continuous regulatory surveillance and keeps its medical devices compliant with applicable requirements: MDR amendments, MDCG guidance, standards amendments, and evolving interoperability mandates. When impactful changes occur, we update our products and alert you if actions are needed on your side.

Medical responsibility remains with the prescribing healthcare professional. Posos is responsible for the conformity and proper functioning of its clinical decision support modules deployed in your software. Our contracts clearly define responsibility boundaries.

Yes. Posos offers 2 integration modes: GraphQL APIs (to keep 100% of your interface) or widgets (for rapid integration with ready-made interfaces). Our widgets integrate into any application architecture — no specific framework dependency required (no mandatory React version, for example). Our APIs are language-agnostic and support healthcare interoperability standards (FHIR R4, SNOMED-CT, CDS Hooks).

CE marking is currently accepted in Great Britain under transitional arrangements (until 2028–2030 depending on device type). Posos is registered with the MHRA and holds the required certification for the UK market. We provide documentation aligned with UK MDR 2002 requirements and support your UK Responsible Person obligations and MHRA registration. See our FAQ for details.

Posos uses deterministic algorithms based on a structured medical knowledge graph — not probabilistic LLM inference. Every recommendation traces through documented medical logic, making it fully auditable. This architecture is inherently aligned with the transparency and explainability expectations emerging from EU medical AI regulations.