Yoctobe Services
Healthcare software development
Generic agencies build software. Yoctobe builds healthcare software — which means architecture accounts for ISO 13485 design controls, test evidence supports notified-body review, and the engineers writing code have read the MDR. Based in Liverpool, we serve UK and EU organisations where the word "audit" carries clinical and legal weight.
What we deliver
Two Programmes. Both Built for Audit.
End-to-end delivery for organisations where software failure has clinical and regulatory consequences. Yoctobe is not a body shop — we bring ISO 13485 quality management discipline, healthcare domain knowledge and integration fluency so your product survives the notified body, scales in production and earns clinician trust rather than workarounds.
Based in Liverpool, we serve UK and EU clients who need software built under accountable processes: ISO 13485-aligned quality management, IEC 62304 software lifecycle controls, risk management to ISO 14971, and technical documentation structured for UKCA and CE marking. Whether you are a healthtech startup seeking first notified-body submission or an established provider extending Promed HIS, the same engineering standards apply.
Custom development
Healthcare software development
Bespoke clinical, operational and integration software — designed for your workflows, security model and compliance obligations. We work as an extension of your team from discovery through deployment, producing maintainable codebases with clear documentation and knowledge transfer. Generic dev shops underestimate clinical nuance, audit requirements and integration debt. Yoctobe engineers for the environment your software will actually run in — a busy ward at shift change, not a conference room demo.
Typical deliverables: patient portals, specialty clinical modules, operational dashboards, FHIR/HL7 connectors, Promed HIS and Prolab LIS extensions, and modernisation of legacy healthcare applications. Engagement models: fixed-scope projects, retained squads and hybrid builds where your in-house team pairs with Yoctobe architects.
- Discovery & architecture — requirements, threat modelling and tech stack selection
- Agile delivery — sprint-based builds with clinical stakeholder review
- Integration — FHIR, HL7, DICOM and legacy system connectors
- Validation support — IQ/OQ/PQ documentation and test evidence
- Knowledge transfer — runbooks, admin guides and handover sessions
Regulated software
SaMD and AIaMD development
Software as a Medical Device and AI-enabled diagnostics built under ISO 13485 and IEC 62304 — with risk management, clinical evaluation and technical documentation aligned to MDR and UKCA requirements. Yoctobe helps you define intended purpose, map classification rules, and build a software lifecycle that notified bodies recognise — not a retrofit documentation sprint weeks before submission.
AIaMD specifics: dataset governance, locked and adaptive model strategies, performance validation, drift monitoring and update controls documented for regulator scrutiny. Post-market: vigilance workflows, periodic safety updates and change impact assessment integrated with your QMS — so enhancements do not invalidate your certificate silently.
- Classification & strategy — intended purpose, rule mapping and regulatory pathway
- QMS-ready SDLC — design controls, SOUP management and change control
- AI/ML lifecycle — dataset governance, model validation and drift monitoring
- Clinical evaluation — evidence planning aligned to MDR Annex XIV
- Notified body support — technical file preparation and audit readiness
Audience
Who Our Services Serve
Yoctobe services fit organisations where software failure has clinical or regulatory consequences — not consumer apps with a healthcare sticker. Healthtech startups preparing first UKCA or CE submission; scale-ups extending AI diagnostics under MDR; hospital groups building custom modules on Promed HIS; laboratory providers needing LIS extensions; and device manufacturers adding SaMD components to hardware portfolios.
Investors and product leaders engage us when internal teams lack IEC 62304 depth or when a failed notified-body audit threatens runway. Compliance officers engage us when they need engineering that produces evidence, not promises. Clinical champions engage us when they need software that respects workflow — built with review gates they can actually attend.
- Healthtech and medtech startups — SaMD/AIaMD from strategy through technical file
- Established providers — custom modules, integrations and platform extensions
- OEM and device firms — companion software and cloud services under MDR
- Investors and CROs — technical due diligence and remediation programmes
Delivery approach
Regulatory Strategy To Release
Yoctobe programmes begin with intended use, users and classification — before significant code is written. Regulatory strategy informs architecture: software items, SOUP boundaries, cybersecurity threat models and clinical evaluation plans run parallel to agile delivery, not after it. Two-week sprints produce demoable increments reviewed by clinical and quality stakeholders; documentation accumulates in your QMS format throughout.
For UK clients we align with MHRA expectations and UKCA pathways; for EU clients we structure files for notified-body review under MDR. GDPR and UK GDPR are treated as design inputs — data minimisation, retention, subprocessors and DPIA support included where personal data processing changes. Post-release, we support change control, vigilance reporting and periodic reviews so your certificate remains defensible.
- Phase 0 — strategy — classification, regulatory pathway and clinical evaluation plan
- Phase 1 — foundation — architecture, QMS integration and SOUP register
- Phase 2 — build & verify — agile sprints with verification evidence per release
- Phase 3 — submission & sustain — technical file, audit support and post-market surveillance
Outcomes
Service Benefits
What clients gain from Yoctobe versus generic software agencies or offshore teams without regulatory depth.
Audit-ready from day one
Design controls, risk files and test evidence accumulate during build — not in a panic before notified-body submission.
AIaMD done properly
Dataset governance, locked models, performance testing and drift monitoring — structured for MDR scrutiny of AI-enabled diagnostics.
Clinical credibility
Engineers who understand healthcare workflows, HL7/FHIR semantics and why clinicians reject software that fights them.
Maintainable codebases
Clean architecture, documented APIs and knowledge transfer — your team or next supplier can sustain the product.
UK & EU regulatory fluency
MDR, UKCA, GDPR and clinical safety expectations woven into delivery — one team for cross-border programmes.
Platform synergy
Extend Promed HIS, Prolab LIS and Yoctobe middleware — faster delivery on proven clinical foundations.
FAQ
Common Questions
Do we need an existing QMS before engaging Yoctobe?
Not always. Startups often engage us to build QMS-ready processes alongside the product. Established manufacturers integrate our deliverables into existing ISO 13485 systems. We adapt to your maturity — gap assessment is part of early discovery.
Can you help with notified-body submission only?
We can remediate documentation and software gaps for audit readiness, but prefer engaging before submission debt accumulates. Technical file preparation, SOUP justification and clinical evaluation support are most cost-effective when aligned with ongoing development.
How is AIaMD different from standard SaMD delivery?
AI introduces dataset bias risk, model drift and update classification questions standard SaMD does not face. We document training data provenance, validation cohorts, performance metrics and change impact for model updates — meeting MDR expectations for AI-enabled devices.
What is the difference between services and Yoctobe solutions?
Solutions are product platforms — Promed HIS, Prolab LIS, middleware and integration — configured and deployed for your organisation. Services are bespoke builds: new SaMD products, custom modules, or integrations beyond standard platform scope. Many clients use both.
Explore Product Platforms
Promed HIS, Prolab LIS and Yoctobe middleware — ready-made platforms we customise and integrate for your organisation.
View Solutions
