Aura Health is a SaMD and DTx digital-health software-engineering partner that architects, codes, and validates solutions on top of the leading commercial platforms, or cloud stacks our clients already own.

Our role is to give life-science organisations the shortest, safest route from clinical concept to globally deployable SaMD product.

Randomized trials and real-world data now show that modern digital-health platforms can halve emergency-department visits, cut readmissions by almost 60 %, and push long-term therapy adherence above 70 %. Regulatory bodies have caught up: EU-MDR and the FDA both require Software as a Medical Device (SaMD) to launch with airtight cybersecurity, clinical evidence, and post-market surveillance from day one.

1. Clinical proof at scale across disease areas

Outcome (index condition)	Usual care	Platform-enabled care
30-day readmissions (mixed high-risk)	0.45 events/patient-year	0.19 events/patient-year
ED visits (same cohort)	0.48 events/patient-year	0.06 events/patient-year
Adherence to long-term drug therapy (HTN & DM)	34 % of doses taken	74 % of doses taken
HbA1c reduction (T2DM, DTx app)	–0 % vs baseline	–0.8 % vs baseline

See Figure 1 – clinical outcomes – platform vs usual care

Four datapoints from multi-centre studies illustrate what happens when evidence-based workflows are translated into production software:

Readmissions –58 % – heart-failure and COPD cohorts, followed through digital alerts and titration advice, came back to the hospital far less often.
ED visits –87 % – early deterioration signals captured by connected devices divert crises into outpatient care.
Adherence +40 pp – behaviour-science nudges and refill automation nearly double chronic-therapy persistence.
HbA1c –0.8 % – algorithmic coaching produces clinically meaningful glycaemic drops in type-2 diabetes.

Aura Health engineers capture those proven care pathways in secure APIs, rule engines, and front-end flows that satisfy IEC 62304 and ISO 13485 from the first sprint.

2. Regulatory reality—SaMD-grade from line 1 of code

Aligned with IMDRF & EU-MDR class rules — we run a formal software-risk classification, generate design inputs, and link each requirement to Jira-based trace matrices.
Cyber-secure by default — threat modelling, penetration testing, and a software bill of materials follow the FDA’s 2023 cybersecurity guidance, so reviewers see risks closed rather than “to-do.”
Documentation on tap — our DevSecOps pipeline spits out V&V summaries, architecture diagrams, and risk files whenever the codebase tags a release, meaning draft MDR Annex II dossiers are minutes away, not months.

3. Architecture that scales without re-validation

Micro-services with FHIR/HL7 APIs — rapid onboarding of Bluetooth devices, lab feeds, and EHRs without monolithic rewrites.
Federated analytics — raw patient data stays inside sovereign EU or Swiss regions; only model deltas move to the cloud, preserving GDPR while enabling machine learning.
DevSecOps pipeline — automated unit tests, static-code analysis, and vulnerability scans compress release cycles to two weeks, even for Class IIa SaMD.
Zero-trust security fabric — every session encrypted with TLS 1.3, every device authenticated by certificate, every action logged immutably.

These aren’t buzzwords—they’re battle-tested patterns we deploy on AWS, Azure, or private OpenShift clusters, chosen to match each client’s compliance envelope and scaling forecast.

4. Health-economic upside

Digital-therapeutic programmes for diabetes report net savings of roughly € 1,400 per patient-year by avoiding complications and admissions. COPD and heart-failure remote-monitoring pilots see >20 % ROI inside the first contract year. Because Aura Health re-uses certified building blocks wherever regulators allow, those economics transfer across therapy lines without the 40–60 % redevelopment overhead typical of single-use apps.

5. Implementation blueprint with Aura Health

Phase	What we do	Typical timeline*
Clinical & regulatory scoping	Risk classification, DPIA, cloud-security architecture	≈ 2 weeks
Configuration & integration	Feature toggles, UI localisation, device/EHR onboarding	4–8 weeks
Verification & validation	> 90 % automated test coverage, fully traceable V&V dossier	2–4 weeks
Launch & RWE dev-ops support	Live-ops dashboard, safety monitoring, technical-file upkeep	Continuous

*Scenario: Class IIa SaMD in a single EU market.

Our engagement doesn’t stop at go-live. We maintain CI/CD, patch cybersecurity CVEs within SLA, and curate post-market surveillance dashboards so your clinical team can focus on outcomes, not log files.

6. What does this mean for your pipeline

A Nordic pharma brand added digital dose-adjustment to a biologic pen in 14 weeks—Aura Health handled BLE firmware bridge, IEC 62366 usability study, and MDR Annex I alignment.
A German cardiology start-up closed a €4 m Series A after we delivered a prototype-to-pilot cloud rebuild that cut latency by 40 % and produced a ready-to-submit 510(k) cybersecurity packet.
A Middle-East hospital network rolled out COPD telemonitoring across 6 clinics; our federated-learning wrapper kept PHI on-prem while central AI models improved exacerbation prediction AUC from 0.68 to 0.79.

Engineering or extending a SaMD-ready platform demands deep regulatory literacy and senior software talent. Aura Health provides both, exactly when you need them.

IEC 62304, ISO 13485, and FDA cybersecurity compliant codebases
Sprint-level V&V evidence and auto-generated MDR / 510(k) artefacts
Seamless device, cloud, and EHR integrations without vendor lock-in

Book a 30-minute technical scoping session with our SaMD engineers at aurahealth.ch/contact.