Medical device R&D software partner
Medical device R&D software for regulated health products
Nearshore engineering for device software, connected health systems, and regulated product teams that need a clear path from feasibility to production.
Medical device research and development for health software teams
Areusdev is a nearshore engineering partner for medical device R&D and health tech software. Founded in 2004, we are 72 people, with 17 in healthtech engineering, and 24 years of healthcare and life sciences delivery.
We help manufacturers and product teams design, build, and harden device software, companion applications, and data interfaces with documentation-aware engineering. Delivery can follow IEC 62304 practices under your ISO 13485 quality system, with awareness of EU MDR, HIPAA, HL7/FHIR, and ISO 27001 controls when your program requires them.
Related: Healthcare technology · ISO 13485 vs IEC 62304 · AI software partner due diligence
From regulated R&D to production software
Prototype. Validate. Scale.
Feasibility spikes, architecture options, and early verification for medical device and health software, with evidence your quality team can review before you commit to a production path.
Transition to production systems
Move from prototype to release candidate with change control, integration tests, and operability under your QMS gates. We align build and release habits to the process you already run.
Documentation-aware device software
Requirements traceability, design notes, and test evidence shaped for IEC 62304-style lifecycle work inside the client's ISO 13485 system. You own conformity decisions; we own engineering clarity.
Connected health and data interfaces
Device-to-cloud paths, companion apps, and HL7/FHIR-aware integration when the product needs clinical or operational data exchange, under the access and privacy rules you set.
AI and edge in regulated R&D
Applied AI, robotics, and edge components for health and life sciences R&D when the use case is clear, with private environments and reproducibility expectations agreed up front.
Other regulated R&D
The same documentation-aware approach supports adjacent regulated R&D, including biotech platforms and advanced software systems that need controlled delivery.
Why work with us on medical device R&D
Healthtech depth
A 17-person healthtech engineering team, inside a 72-person company with 24 years in healthcare and life sciences delivery from Romania in the EU.
QMS-aligned engineering
We build under your ISO 13485 processes and IEC 62304 practices, so engineering evidence fits the quality system your auditors already know.
Evidence over slogans
Architecture assumptions, SBOM-minded component visibility when useful, and release evidence your security and compliance reviewers can inspect. See also CRA vs MDR for health software.
Delivery framework
Practices we work under
We align delivery to the governance, quality, and security controls required by your program.
- IEC 62304 software lifecycle practices under the client's ISO 13485 QMS
- EU MDR-aware device software delivery (manufacturer owns classification)
- HIPAA-aware handling when US health data is in scope
- HL7/FHIR-aware integration where the program needs it
- ISO 27001-aware security and privacy expectations in delivery
Selected work
Medical device and health R&D examples
Due diligence
Medical device R&D software FAQ
Clear answers for product, quality, engineering, and regulatory stakeholders.
What does medical device R&D software work cover at Areusdev?
It covers software for connected medical devices and health tech: architecture, implementation, integration, verification support, and documentation-aware delivery under your quality system. Typical scope includes device software, companion apps, data paths, and interfaces such as HL7 or FHIR when the program needs them. Areusdev works as a nearshore engineering partner from Romania in the EU. We do not classify your product or certify MDR conformity.
Do you work under IEC 62304 and the client's ISO 13485 QMS?
Yes. Delivery can follow IEC 62304 software lifecycle practices inside the client's ISO 13485 quality management system. Your QMS owns release gates, documentation templates, and conformity decisions. We align engineering work, evidence, and change control to the processes you and your notified body or auditor require.
Have you built health software that went through ISO 13485 and ISO 27001 certification?
Yes, on the RoADN project. Areusdev built Romania's first genetic database through an EU-financed program, and together with Genetic Lab the Iasi lab obtained ISO 13485 and ISO 27001 certification. On device programs, we build inside the client's own ISO 13485 quality system, and the manufacturer keeps ownership of certification and conformity decisions.
Can you support EU MDR and HIPAA-aware delivery?
Yes, with awareness of EU MDR expectations for device software and HIPAA-aware handling when US health data is in scope. Counsel and the manufacturer decide product qualification and regulatory strategy. Areusdev records the assumptions you give us and builds software and integration evidence under your governance. We do not provide legal advice or issue CE marking.
Which medical and health R&D programs has Areusdev worked on?
Public examples include NerveRepack, an EU consortium building bidirectional neural interfaces for prostheses and exoskeletons, where Areusdev contributes engineering, and RoADN, where Areusdev built Romania's first genetic database in an EU-financed project. Founded in 2004, Areusdev has 72 people, 17 of them in healthtech engineering, and 24 years of healthcare and life sciences delivery.
Who is medical device R&D engineering for, and who should lead compliance?
It fits medtech manufacturers, healthtech product teams, and life sciences groups that need software built under a formal QMS. Your regulatory, quality, and legal stakeholders lead classification, clinical claims, and conformity assessment. Areusdev supplies engineering, documentation support, and nearshore capacity. Start with our CRA versus MDR resource or contact us for an architecture discussion.
Plan your medical device R&D software work
Bring your intended use, QMS constraints, and integration map. Areusdev will help you prototype, validate, and scale the software path under your governance.
Contact us