Development and consulting partner for SaMD, AI medical devices and Digital Therapeutics from concept phase to market approval.
Aura Health d.o.o.
Zagreb (Headquarters) · Zurich · Berlin · CopenhagenNew on Amplifa
About Aura Health
Aura Health d.o.o. is a full-service partner specializing in Software as a Medical Device (SaMD), AI medical devices (AIaMD) and connected medical devices, headquartered in Zagreb (Croatia) with offices in Zurich, Berlin and Copenhagen. The company supports MedTech and Pharma customers across the entire lifecycle: from concept, software development and embedded engineering, regulatory compliance (EU MDR, IVDR, FDA QMSR), quality management systems per ISO 13485, clinical evaluation and studies, to Health Economics (HEOR), Market Access, intellectual property and Medical Affairs. Aura Health can act as Critical Supplier or Legal Manufacturer and thus assume the manufacturer responsibility for digital therapeutics and patient companion software, while partners retain commercial ownership. Focus areas include chronic disease management, wearables and implants as well as Digital Therapeutics. The development and quality processes are certified to ISO 13485:2016 by a BSI-accredited Notified Body.
- Site
- Zagreb
- Processes
- SaMD, AI Medical Device Development, Regulatory Compliance (EU MDR 2017/745, IVDR 2017/746, FDA QMSR 21 CFR Part 820), Quality Assurance / QMS per ISO 13485:2016, IEC 62304, ISO 14971, IEC 82304, IEC 81001-5-1, IEC, Clinical Evaluation / Clinical Research (ISO 14155, ISO 20916), Health Economics (HEOR, Cost-Effectiveness, Budget Impact), Market Access (Pricing, Reimbursement, Go-to-Market), Intellectual Property (Patents, Freedom to Operate, Portfolio Management), Medical Affairs / Regulatory Affairs Consulting
- Materials
- SaMD and AI Medical Device Development, Regulatory Compliance (EU MDR, IVDR, FDA QMSR), Quality Assurance / QMS Implementation (ISO 13485), Clinical Evaluation and Clinical Studies (ISO 14155, ISO 20916), Health Economics / Market Access, Intellectual Property, Digital Therapeutics and Patient Companions, Usability Engineering (IEC 62366)
- Certificates
- ISO 13485:2016, ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), IEC 62366 (Usability), GAMP 5, ISO 14155 (Clinical Investigation)
- Industries
- MedTech, Pharma, Digital Health / Digital Therapeutics, Biotechnology, Wearables and Implants, Chronic Disease Management
- 01
Concept and User Research
- 02
SaMD/AIaMD software development (IEC 62304)
- 03
Risk management and usability (ISO 14971, IEC 62366)
- 04
Quality assurance and technical dossier
- 05
Clinical evaluation and studies
- 06
Market approval and CE certification
- 07
Market access and commercialization strategy
- 08
Post-Market Surveillance and Vigilance
Services and applied standards
SaMD and AI Medical Device Development
Development of regulated medical software with software lifecycle per IEC 62304 and health software safety per IEC 82304 and IEC 81001-5-1.
Regulatory Compliance (EU MDR, IVDR, FDA QMSR)
Conformity assessment, technical documentation per MDR Annex II/III, GSPR checklists and support with Notified Bodies.
Quality Assurance / QMS Implementation (ISO 13485)
Setup, gap analysis and audit preparation of QMS including CAPA, supplier control and FDA inspection preparation.
Clinical Evaluation and Clinical Studies (ISO 14155, ISO 20916)
End-to-end clinical evaluations and studies for software-based medical devices before and after market entry.
Health Economics / Market Access
Health-economic modeling, budget impact and cost-effectiveness analyses as well as pricing, reimbursement and go-to-market strategies.
Intellectual Property
Patent identification, freedom-to-operate analyses and portfolio management for software, algorithms and designs.
Digital Therapeutics and Patient Companions
Full-lifecycle development and operation of DTx solutions, including taking on the role of Legal Manufacturer.
Usability Engineering (IEC 62366)
Application of usability engineering requirements in risk management and UI/UX design.
Cybersecurity for Software (UL 2900-2-1, GAMP 5)
Risk-based approach to cybersecurity of connected devices and for GxP-compliant systems.
Locations
Zagreb
HRHeadquarters
- Materials
- SaMD/AIaMD development, Regulatory, QA, Clinical Research
- Software development and QMS infrastructure per ISO 13485
Zurich
CHOffice / Site
- Materials
- Regulatory consulting, Market Access
Berlin
DEOffice / Site (Potsdamer Platz 1)
- Materials
- Regulatory consulting, Market Access
Copenhagen
DKOffice / Site (Ny Carlsberg Vej 80)
- Materials
- Regulatory consulting, Market Access
Service Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| SaMD, AI Medical Device DevelopmentEngineering | – | – | – | – | – |
| Regulatory Compliance (EU MDR 2017/745, IVDR 2017/746, FDA QMSR 21 CFR Part 820)Engineering | – | – | – | – | – |
| Quality Assurance / QMS per ISO 13485:2016, IEC 62304, ISO 14971, IEC 82304, IEC 81001-5-1, IECTesting | – | – | – | – | – |
| Clinical Evaluation / Clinical Research (ISO 14155, ISO 20916)Testing | – | – | – | – | – |
| Health Economics (HEOR, Cost-Effectiveness, Budget Impact)Engineering | – | – | – | – | – |
| Market Access (Pricing, Reimbursement, Go-to-Market)Engineering | – | – | – | – | – |
| Intellectual Property (Patents, Freedom to Operate, Portfolio Management)Engineering | – | – | – | – | – |
| Medical Affairs / Regulatory Affairs ConsultingEngineering | – | – | – | – | – |
| Development of wearables, implantables and connected medical devices (software integration)Engineering | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
Aura Health's development activities are controlled and structured by a quality management system certified to ISO 13485:2016 (BSI-accredited Notified Body). In addition, ISO 14971 (risk management), IEC 62304, IEC 82304, IEC 81001-5-1, IEC 62366, UL 2900-2-1, GAMP 5, ISO 14155 and ISO 20916 are applied.
| Evidence | Zagreb | Zurich | Berlin | Copenhagen |
|---|---|---|---|---|
| ISO 13485:2016 | ||||
| ISO 14971 (Risk Management) | ||||
| IEC 62304 (Software Lifecycle) | ||||
| IEC 62366 (Usability) | ||||
| GAMP 5 | ||||
| ISO 14155 (Clinical Investigation) |