Regulation & SaMD
Medical device software
What is SaMD (Software as a Medical Device)?
SaMD is software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device. In the UK, this includes software used for diagnosis, prevention, monitoring, prediction, prognosis or alleviation of disease. The MHRA actively ensures regulations remain suitable for these technologies.
What is AIaMD (Artificial Intelligence as a Medical Device)?
AIaMD is a subset of SaMD that uses artificial intelligence — including machine learning — to achieve its intended medical purpose. This spans medical imaging analysis, diagnostic support, predictive analytics and personalised treatment recommendations. The MHRA is developing regulations to ensure AIaMD safety and effectiveness in the UK.
Why is regulatory compliance important for SaMD and AIaMD?
These technologies often play a direct role in healthcare decisions. Non-compliance risks patient harm and legal consequences for manufacturers. Standards such as IEC 62304 and MDR principles are essential for market access and clinician trust — demonstrating rigorous safety and performance requirements were met during development.
What regulations does Yoctobe help with?
Yoctobe navigates the UK regulatory landscape for SaMD and AIaMD, including IEC 62304 software lifecycle processes and MDR principles aligned with UKCA pathways. We help ensure your software meets standards for market access and patient safety.
What is Yoctobe's approach to SaMD and AIaMD development?
A comprehensive, risk-based methodology with regulatory compliance at the core — from intended use and classification through design, verification, regulatory submission support and post-market surveillance. Our process aligns with IEC 62304 and emphasises quality, safety and effectiveness throughout.
Do you offer custom SaMD and AIaMD development?
Yes. Yoctobe provides custom development tailored to healthcare organisations and innovators in the UK. We collaborate closely to translate your vision into compliant, high-quality medical device software using current technologies and regulatory best practices. See our SaMD & AIaMD development service for programme detail.
How long does SaMD development take to reach CE marking?
Timelines depend on device class, clinical evidence requirements and team readiness. A Class I self-declared product with literature-based clinical evaluation may reach market in months; Class IIa and above with notified body review typically require twelve to twenty-four months from stable requirements. We provide a milestone plan after discovery so you can align funding, clinical studies and go-to-market dates.
Do you act as the legal manufacturer?
Yoctobe typically delivers SaMD development as an engineering and regulatory documentation partner. The legal manufacturer remains your organisation unless a specific commercial arrangement is agreed. We support your QMS integration, technical file ownership and notified body interactions while you retain product liability and market authorisation.
How do you handle software updates after launch?
All post-market changes follow your change control process. We assess regulatory impact — whether an update is a minor correction or requires new clinical evaluation — and deliver regression test evidence. For AIaMD, retraining triggers are defined upfront so performance drift is detected and managed before it affects patient safety.
Solutions
Clinical platforms
Can we deploy one solution or do we need the full stack?
Each platform stands alone: Prolab LIS with your existing EHR, middleware without replacing your LIS, or data integration only. Many customers start with one solution and expand — shared architecture makes later connections faster and cheaper than bolting on unrelated products.
What does implementation typically involve?
Discovery, configuration, integration, UAT and go-live — duration depends on sites, devices and external feeds. We run sandbox environments early so clinical users validate workflows before production. Hypercare covers the first weeks; ongoing support and enhancement retain the same engineering team.
Do you replace our existing PAS or laboratory system?
Not necessarily. Yoctobe often coexists with legacy systems during migration — middleware and data integration bridge old and new until you are ready to cut over. Rip-and-replace is a business decision; our job is to make whichever path you choose technically sound and auditable.
Promed HIS · Practice management
Can Promed HIS replace our existing PAS and EHR?
Yes. Promed HIS covers registration, scheduling, clinical documentation, inpatient management, pharmacy, billing and reporting in one practice management system. Yoctobe maps your current systems during discovery and plans a phased cutover — often starting with outpatient clinics before expanding to inpatient and ancillary services. Full PMS page →
How does Promed HIS integrate with our laboratory?
If you run Prolab LIS, integration is native — orders and results share patient identifiers and LOINC-coded structured data. For third-party LIS platforms, Yoctobe builds HL7 v2 or FHIR interfaces with monitoring and error quarantine. Analyser connectivity is handled by Yoctobe middleware where direct instrument feeds are required.
Is Promed HIS suitable for UK GDPR and NHS data handling?
Promed HIS is designed for UK GDPR compliance with role-based access, audit trails, consent management and configurable data retention. Hosting options include UK-based cloud infrastructure. Yoctobe holds ISO 27001 certification and follows IEC 62304 software lifecycle practices for regulated healthcare delivery.
What does a Promed HIS demonstration include?
A typical demo walks through patient registration, a clinical consultation with form-based documentation, lab ordering, result review, e-prescribing and invoice generation — using workflows relevant to your specialty. Yoctobe can also show bed management, queue screens and integration dashboards if those modules are in scope.
Prolab LIS · Laboratory
Does Prolab LIS work without Promed HIS?
Yes. Prolab LIS operates as a standalone laboratory platform with its own order entry, sample management and reporting modules. Yoctobe builds HL7 v2 or FHIR interfaces to third-party EHR and PAS systems. Where both Promed HIS and Prolab LIS are deployed, integration is native and requires no separate interface project. Full LIS page →
What is the relationship between Yoctobe and Prolab LIS?
Yoctobe develops, deploys and supports Prolab LIS from Liverpool. The product brand and commercial site live at prolablis.com; Yoctobe.com covers the wider platform family — Promed HIS, middleware, data integration and regulated software services.
Which analysers can you interface?
Yoctobe middleware supports a growing catalogue of haematology, biochemistry, immunology and point-of-care devices via ASTM, HL7 and proprietary serial or TCP protocols. During discovery, Yoctobe confirms driver availability for your instrument fleet and schedules parallel validation runs before live result posting.
How does Prolab LIS support accreditation and audit?
Electronic signatures, QC logs, sample traceability and user activity audit trails are built into the platform. Validation rules enforce delta checks and critical limits before results release. Reports and audit exports support ISO 15189 assessments without manual log compilation.
Can we migrate from our current LIS?
Yoctobe migrates test catalogues, reference ranges, active orders and historical results where source systems permit export. Migration runs in parallel with instrument interfacing and workflow configuration — cutover is planned around minimal disruption to live bench operations, typically over a weekend or phased by department.
Medical instrument middleware
Can Yoctobe middleware connect to our existing LIS or EHR?
Yes. Middleware routes validated messages to Prolab LIS, Promed HIS or third-party systems via HL7 v2, FHIR or proprietary APIs. Discovery confirms target schema, message types and monitoring requirements per destination. Full middleware page →
What happens when an instrument message fails validation?
Failed messages quarantine rather than silently drop. Operations dashboards flag checksum errors and mapping failures; staff inspect raw messages, correct rules and replay once validated.
Is middleware available standalone?
Yes — independent of Prolab LIS and Promed HIS, with the same multi-layer architecture, monitoring and Liverpool-based support.
How do you validate new instrument drivers?
Parallel validation in staging; field mappings and unit conversions verified before production routing. Driver updates follow IEC 62304 change control with regression testing.
What standards and protocols does middleware support?
HL7, FHIR, CDA, CCD, X12, JSON, XML, EDI and flat files. Communication includes LLP, TCP/IP, HTTP/HTTPS, FTP/SFTP, database connections, SOAP, REST and file system interfaces — ensuring compatibility across diverse platforms.
Is Yoctobe middleware secure and scalable?
Yes. We implement end-to-end encryption, strong authentication, access controls and comprehensive audit logs — designed to comply with healthcare data protection regulations. The architecture is modular and cloud-native, handling growing data volumes with reusable interface modules and load balancing for reliable performance at high transaction volumes.
Healthcare data integration
Can you integrate with our existing PAS or EHR without replacing it?
Yes. Most Yoctobe programmes bridge legacy HL7 v2 and proprietary APIs to modern FHIR consumers — or the reverse. We design incremental connectivity so you retire brittle interfaces on a controlled schedule rather than betting on a big-bang migration. Full data integration page →
How do you handle UK GDPR and EU data protection?
We document lawful basis, data minimisation, retention and subprocessors as part of discovery. Interfaces use encryption in transit and at rest where required; access is role-controlled and logged. Cross-border flows include transfer mechanism assessment — SCCs or adequacy as applicable.
What validation evidence do you provide for regulated environments?
Test plans, executed scripts, defect logs and release notes suitable for IQ/OQ/PQ folders and SaMD technical documentation. For IEC 62304 environments we align software items, SOUP registers and change records with your QMS — not a separate paperwork stream.
How long does a typical integration programme take?
Scope drives timeline: a single HL7 results feed may take weeks; multi-site FHIR, DICOM and master data programmes take months. Discovery produces a fixed-phase plan with sandbox milestones before production cutover — you see working interfaces early, not a surprise at go-live.
Services
Bespoke programmes
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.
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.
Healthcare software development
How is healthcare software development different from general custom software?
Healthcare systems operate under stricter security, privacy and often regulatory constraints. Clinical workflows have safety implications; data must flow correctly between systems; and audit trails are non-negotiable. We apply domain knowledge — terminology standards, integration patterns and validation expectations — that generalist agencies typically lack. Full service page →
Do you only build on Promed HIS and Prolab LIS?
No. We customise and extend our own platforms where they fit your needs, and we build standalone applications, middleware and integrations against third-party EHRs, LIS products and legacy systems. The right approach depends on your existing estate and long-term strategy.
Can you work alongside our internal IT team?
Yes — that is our preferred model for many provider organisations. We complement your team with healthcare-specific engineering capacity, follow your change management processes and leave documentation so internal staff can sustain the solution.
What technologies do you use?
Stack selection follows project requirements — typically modern web frameworks for clinical UIs, RESTful and FHIR APIs, message queues for HL7 processing and cloud or on-premise hosting to match your data residency policy. We favour maintainable, well-supported technologies over novelty.
Working with Yoctobe
Why is medical device integration important?
Seamless integration creates a connected healthcare ecosystem — complete, accurate patient information on demand, fewer transcription errors, streamlined workflows, remote monitoring and cost savings through reduced unnecessary tests and admissions.
What devices and systems can Yoctobe integrate?
Diagnostic equipment, monitoring devices, imaging systems, infusion pumps, IoMT sensors and wearables — connected to EHR, LIS, RIS, PACS, medical databases and automation systems regardless of manufacturer or data format.
What is Yoctobe's UK healthcare experience?
Yoctobe serves the UK healthcare industry from Liverpool with strong understanding of NHS challenges and opportunities — helping organisations leverage compliant software and integrated devices to improve outcomes and operational efficiency.
How can we get started?
Contact us via Contact Us or call directly. We offer an initial consultation to discuss your goals and outline how our platforms, SaMD/AIaMD development and integration expertise can support your programme in the UK healthcare market.
Still have questions?
Browse the knowledge base or open a support ticket — our team is available 24/7.
