Healthcare Software · SaMD · Data Integration
Empowering healthcare software
Regulatory-compliant SaMD and AIaMD development, connected platforms and healthcare data integration — built for providers who need software that passes audit, not just demo day.
What we offer
Services and solutions
Services
End-to-end programmes for organisations where software failure has clinical or regulatory consequences. ISO 13485-aligned processes, healthcare domain knowledge and integration fluency — built for certification, not retrofitted before audit.
- Healthcare software development — custom clinical platforms, QMS-ready architecture and product engineering for UK and EU providers
- Regulatory-compliant SaMD and AIaMD — ISO 13485, IEC 62304 and MDR-aligned classification, clinical evaluation and technical documentation
- Healthcare data integration — FHIR, HL7 and DICOM pipelines connecting EMRs, imaging, billing and patient portals
- Medical instrument integration — bidirectional ASTM/HL7 middleware connecting analysers, LIS and clinical records
Solutions
Production platforms Yoctobe builds and operates. Promed HIS runs seven interconnected modules on one patient timeline. Prolab LIS manages the complete laboratory workflow. Middleware and data integration connect your wider estate.
- Promed HIS — hospital information system for practices, clinics and hospitals. promedhis.com
- Prolab LIS — laboratory information system with orders, traceability, QC and instrument middleware. prolablis.com
Our Expertise
We Build SaMD and AIaMD That Pass Audit
Most SaMD programmes hit the notified body with documentation assembled under deadline pressure — classification rationale written backwards, clinical evaluation evidence scraped together, software lifecycle records that tell the story of a scramble. Yoctobe was built to do the opposite: ISO 13485 design controls, IEC 62304 lifecycle management and MDR-aligned technical documentation run parallel to engineering from sprint one.
Healthcare Software Development
Custom platforms from discovery through deployment — clinical workflows, integration and long-term support from Liverpool.
SaMD & AIaMD Development
Class I–III software as a medical device and AI-enabled diagnostics — risk management, clinical evaluation and technical documentation.
Healthcare Data Integration
FHIR, HL7 and DICOM pipelines — real-time, secure and auditable data flows across your estate.
SaMD & regulatory software
How we build regulatory-compliant SaMD
ISO 13485, IEC 62304 and MDR-aligned delivery — from QMS foundation through classification, clinical evaluation and technical documentation.
About Yoctobe
A Decade of Clinical Software. Live, Not Demo.
Founded in Germany and operating from Liverpool, Yoctobe has built and deployed healthcare software that runs in live clinical environments — Promed HIS, Prolab LIS and the middleware connecting instruments to records. Institut Pasteur, TotalEnergies and bioMérieux trust these platforms in production. The same engineering team serves providers across Europe who need software that works on a ward, not just a demo screen.
2015
Founding year
180+
Customers
5
Strategic partners
11
Major projects
Mission
Our Mission
Build healthcare software that clinicians trust, regulators can audit and engineers can maintain — deployed in real hospitals, not just presented at industry conferences.
Vision
Our Vision
A healthcare system where every clinical tool connects cleanly, behaves predictably under load and earns its place on the ward through evidence — not marketing spend.
Trusted By
Deployed and trusted by leading institutions
From hospital networks across North Africa to Institut Pasteur in Paris and TotalEnergies corporate health — Yoctobe platforms run in live clinical environments where software failure is not an option.
Four Platforms. One Architecture.
Production platforms deployed in hospitals and laboratories across Europe. Promed HIS and Prolab LIS share architecture, patient identifiers and the same engineering team — connect them to your existing estate with Yoctobe middleware and data integration.
Promed HIS
Seven interconnected modules — EHR, laboratory, pharmacy, RIS/PACS, billing, stock management and clinical AI — on one patient record. No re-keying between clinical and finance. No separate session to check lab results.
Yoctobe overviewExplore on promedhis.com
Full module hub — EHR, pharmacy, RIS/PACS, billing, ERP and clinical AI on one platform.
promedhis.comProlab LIS
Laboratory information system — orders, barcode traceability, QC, validation and structured reports.
Yoctobe overviewExplore on prolablis.com
Full LIS feature tour — dashboard, automates, validation, stocks, billing and patient portal.
prolablis.comMedical instrument middleware · Healthcare data integration · All solutions
Yoctobe Featured in Liverpool’s ‘Ones to Watch’ Business Roundtable
SaMD Classification Explained: Navigating EU & UK Regulatory Requirements
Offline-First Hospital Systems for Constrained Networks
In many hospitals the network is not a utility you assume; it is a weather pattern. Clinics lose the uplink during storms, shared microwave links saturate at noon, and power events take the data centre offline while wards keep treating patients. Offline-first design is how custo…
MDR Evidence Packs for SaMD Software Updates
A SaMD release is not finished when the build is green. Under the EU Medical Device Regulation, a software update is either a controlled change with evidence or an uncontrolled drift of the device on the market. Teams that treat patches as “just IT” discover the gap when a notif…
Audit Trails That Survive Scrutiny in Custom Healthcare Software
When a hospital auditor asks who changed a medication order, when they changed it, and why, the answer cannot be a reconstructed story from chat logs. Custom healthcare software either produces an immutable audit trail or it produces theatre. The difference shows up the moment s…
Middleware vs Point-to-Point Device Interfaces
Connecting each analyser or medical device straight to the clinical system feels fastest on the first interface. By the tenth, every firmware upgrade is a mini-project, mappings drift, and nobody can say which message produced a wrong result. Middleware versus point-to-point is …
