Saifo Ltd
ServicesApproachWorkAboutTeamBook a call
Healthcare & medical device software

Practical AI,
applied to healthcare
software.

Saifo helps medical device manufacturers, NHS teams and health-tech companies use AI to build better software, faster — without compromising on safety, quality or compliance.

Book a consultationSee how we work
15+
Years in regulated healthcare software
62304
IEC 62304 & ISO 13485 delivery
3
Sectors: NHS, MedTech, health-tech
AI
In the loop, with humans accountable
Services

What we help teams with.

From strategy to shipped software — grounded in the standards and evidence that regulated healthcare demands.

AI strategy & adoption

Assess where AI genuinely adds value across your product and delivery, then put it into practice with a plan your team can own.

Medical device software

Design and build software as a medical device to IEC 62304, ISO 13485 and IEC 62366 — with the documentation to match.

Workflow & delivery automation

Automate manual steps across engineering, QA and regulatory work, so people spend their time on judgement, not repetition.

Regulatory-ready systems

Architect systems that hold up to audit: traceability, risk management and evidence built in from the first commit.

Data & interoperability

Connect clinical and device data cleanly — HL7, FHIR and DICOM — for products that fit into real care pathways.

Fractional technical leadership

Act as your interim CTO or lead engineer — setting direction, raising the bar and de-risking delivery.

Approach

How we use AI to drive efficiency.

AI accelerates the work; accountability stays with people. Every AI-assisted output is reviewed, traceable and fit for a regulated setting.

01

Clinical & regulatory documentation

Draft, structure and maintain technical files, test evidence and clinical documentation with AI in the loop — reviewed and signed off by a human.

02

Engineering acceleration

LLM-assisted code review, test generation and legacy modernisation that keeps quality high and cycle times low.

03

Faster submissions

Assemble and cross-check regulatory submissions so review cycles shrink from weeks to days, with a clear audit trail.

04

Research & discovery

Accelerate literature review, competitive analysis and early R&D — surfacing evidence quickly without cutting corners.

Selected work

Outcomes, not activity.

A few representative engagements. Details are illustrative — replace with your own.

Medical device manufacturer
2.5×
Faster technical-file updates

Introduced an AI-assisted documentation pipeline tied directly to the codebase, keeping the technical file current with every release and freeing engineers to focus on the product.

NHS digital team
6wk → 4d
Clinical coding backlog

Built an LLM-assisted triage tool with clinician review, deployed inside existing information-governance controls — cutting a six-week backlog to four days.

Health-tech scale-up
5 weeks
FHIR integration to go-live

Acted as fractional technical lead through architecture, build and first customer go-live — shipping a FHIR integration in five weeks against an estimate of five months.

About

A consultancy built for regulated healthcare software.

Saifo is a specialist consultancy focused entirely on healthcare and medical device software — the kind of work where safety, evidence and traceability are not optional. Our consultants each bring more than fifteen years in the sector.

We help teams apply AI where it earns its place: removing manual effort, shortening delivery cycles and keeping quality high, all within the standards that regulated environments require.

SectorsNHS & public sector, medical devices, health-tech
StandardsIEC 62304, ISO 13485, IEC 62366, ISO 14971
DataHL7, FHIR, DICOM, interoperability
Ways of workingAdvisory, fractional leadership, hands-on delivery
Based inUnited Kingdom · working remotely & on-site
Ismael Saifo, Founder & Principal Consultant
Who we are
Ismael Saifo
Founder & Principal Consultant

Ismael is a senior medical device software and systems engineer with more than fifteen years delivering connected, sensor-based devices in FDA- and MDR-regulated environments. He has built and verified software for platforms including Smith&Nephew’s LEAF patient-monitoring wearable and Stryker’s MotionSense — spanning firmware, wireless (BLE) connectivity, mobile and cloud, all under ISO 13485, IEC 62304, FDA 21 CFR Part 820 and EU MDR design controls.

Today he leads AI engineering for secure NHS and healthcare data platforms, bringing the same discipline — traceability, automated testing and release governance — to clinical systems. He founded Saifo to help teams pair that rigour with modern AI: accelerating delivery and cutting manual effort without ever compromising the safety, evidence and standards regulated healthcare demands. He leads every engagement personally, pairing hands-on delivery with senior technical direction.

Let’s talk about your product.

Whether you are scoping an AI initiative, building software as a medical device, or need senior hands on delivery — we would be glad to talk it through.

Book a consultation callSend me an email