03
Oct
Yoctobe Featured in Liverpool’s ‘Ones to Watch’ Business Roundtable
We're proud to share that Yoctobe was recently featured in a high-profile business roundtable hosted by CG Pro...
Articles
31
Mar
SaMD Classification Explained: Navigating EU & UK Regulatory Requirements
Are you developing software for healthcare applications? Understanding SaMD classification is crucial to your ...
26
Sep
Healthcare Data Residency and Sovereignty by Design
Data residency conversations in healthcare still start too late: usually after a cloud region is chosen or a vendor contract is signed. Sovereignty is not a checkbox on a procurement form. It is an integration architecture problem: where data may live, who may process it, and wh…
23
Sep
Clinical Decision Support: Logging, Override, and Liability
Clinical decision support and AI assist tools rarely fail in dramatic ways. They fail in the quiet gap between a suggestion on screen and a decision in the record. When that gap is not logged, override trails evaporate, and liability debates become speculation rather than eviden…
20
Sep
Usability Engineering for SaMD (IEC 62366)
For Software as a Medical Device, a confusing screen is not a UX debt item — it is a hazard. IEC 62366 frames usability engineering as a systematic way to find use errors, reduce them through design, and produce evidence that intended users can operate the software safely. Teams…
17
Sep
HL7 v2 and FHIR Coexistence in Hospital Integration
Most hospitals will not wake up one Monday on pure FHIR. They run decades of HL7 version 2 feeds for ADT, orders, and results, while new programmes demand FHIR APIs for apps, national exchanges, and analytics. The winning strategy is coexistence with clear contracts — not a big-…
14
Sep
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…
11
Sep
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…
08
Sep
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…
05
Sep
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 …
02
Sep
AIaMD: When Clinical AI Becomes a Medical Device
Not every clinical algorithm is a medical device, and not every “AI feature” in a health app is harmless productivity software. The line is intended use: what the software claims for diagnosis, treatment, prevention, or clinical decisions, and how far users are expected to rely …
30
Aug
Treat FHIR as an Integration Contract, Not a Buzzword
Calling an interface “FHIR” does not make it interoperable. FHIR becomes valuable when it is treated as a deployable contract: agreed profiles, identity rules, terminology bindings, and acknowledgement behaviour that both sides can test before go-live. Without that contract, you…
