Top 10 Healthcare Software Development Companies in Europe (2026)

Looking for a healthcare software development company in Europe? This guide lists specialized partners that design and build compliant, secure, and interoperable digital health products — including HealthTech and MedTech solutions.European healthcare systems in 2026 face three structural challenges:

• Ageing populations requiring continuous, personalized care

• Regulatory pressure for interoperability across fragmented national health records

• Rapid adoption of AI-driven clinical tools aimed at reducing clinician workload and improving diagnostic accuracy

These forces are accelerating investment in digital health. The global digital health market is projected to reach approximately USD 483 billion in 2026, according to Precedence Research.

However, building healthcare software is fundamentally different from building general-purpose commercial applications. In e-commerce, a poorly designed checkout flow reduces conversions. In healthcare, a poorly designed medication management system can compromise patient safety. That difference makes domain expertise, regulatory literacy, and understanding of clinical workflows non-negotiable when selecting a development partner.

This article provides a curated shortlist of custom healthcare software development companies in Europe. It focuses on firms that:

• Deliver bespoke HealthTech or MedTech products

• Operate in regulated medical environments

• Support projects from discovery through deployment

• Build interoperable, secure, and scalable systems

It does not include EHR vendors or off-the-shelf software platforms.

Transparency Note: Monterail is included in this list. We are the publisher and operate in this space. The same selection criteria have been applied to our company as to every other firm featured here.

TL;DR

This guide compares ten Europe-based healthcare software development companies that build custom, compliance-ready digital health products — not off-the-shelf platforms. It explains why healthcare software requires specialized expertise in GDPR, MDR/IVDR, IEC 62304, ISO 13485, ISO 27001, interoperability (HL7/FHIR), and regulated QA processes, and provides a practical checklist to evaluate vendors. The featured companies vary in scale and specialization — from HealthTech MVP development to enterprise-grade MedTech and pharmaceutical platforms — but all demonstrate documented experience operating within Europe’s high regulatory standards. In healthcare, choosing a software partner is not just a delivery decision; it is a long-term decision about compliance, safety, and risk management.

What Does “Healthcare Software Company” Mean?

A healthcare software development company refers to a team that designs and builds custom digital health solutions tailored to a client's specific clinical, operational, and regulatory requirements. It does not refer to vendors that sell licenses to proprietary, off-the-shelf healthcare platforms.

Healthcare software development in Europe typically involves:

• Compliance with MDR / IVDR regulations

• Secure handling of sensitive health data under GDPR

• Integration with legacy hospital systems and national EHR infrastructures

• Alignment with clinical workflows and safety standards

• Documentation and quality management processes suitable for regulated environments

In these cases, adapting internal processes to fit a fixed product can create compliance risk, operational inefficiencies, or clinical friction. Custom development aligns the software with the healthcare provider, not the other way around.

How to Evaluate the top Healthcare Software Development Companies in Europe?

Healthcare is often highlighted on software agency websites because it signals complexity, regulatory rigor, and high delivery standards. However, the presence of healthcare in a portfolio does not automatically indicate deep domain expertise.

In practice, many generalist agencies underestimate the operational, clinical, and regulatory constraints that define digital health projects. Superficial experience in the sector is not equivalent to building compliant, safety-aware, production-grade healthcare systems.

Why the European Context Matters

This shortlist focuses specifically on Europe for a reason. The European regulatory framework sets one of the highest global standards for digital health development. Companies operating successfully in this environment demonstrate structured compliance literacy and process maturity.

Key regulatory frameworks include:

• GDPR — strict requirements for personal and health data protection

• MDR (Medical Device Regulation) — governing medical device software classification and lifecycle

• IVDR (In Vitro Diagnostic Regulation) — covering diagnostic-related software

• European Health Data Space (EHDS) — an emerging framework shaping cross-border health data use Source

Selection Criteria for This Shortlist

To ensure consistency and practical value, each company included was evaluated against five clear criteria:

• European Roots or Delivery Footprint. The companies here are either headquartered in Europe or operate significant delivery hubs across the continent. Geographic proximity matters for GDPR alignment, time-zone collaboration, and familiarity with European health system dynamics.

• A Dedicated Healthcare or Life Sciences Practice. Every company on this list has a named, developed healthcare practice — not just a few relevant past projects tucked into a generalist portfolio.

• Demonstrated Regulated-Industry Literacy. This means publicly demonstrable familiarity with the standards that govern digital health: GDPR, MDR/IVDR, IEC 62304, ISO 13485, ISO 27001. A partner who discovers these requirements mid-project is a liability, not an asset.

• Full-Lifecycle Product Capability. The best engagements in this space run from early discovery and clinical user research through iterative build to long-term post-launch support. We prioritised partners who are comfortable owning that entire arc, not just the development phase.

• Publicly Verifiable Proof of Work. Named case studies, documented client outcomes, verifiable industry recognition — claims without evidence weren't enough to make the cut.

The Top Healthcare Software Development Companies in Europe

Monterail (Poland)

Monterail is a product engineering company building digital products across fintech, SaaS, and healthcare — with a growing and publicly documented specialisation in HealthTech and MedTech. 

Founded in Wrocław in 2011, they've worked with both early-stage startups and established companies across Europe and beyond. In healthcare, their work tends to sit at the intersection of consumer usability and clinical rigour — patient-facing apps, wearable integrations, and data platforms where getting the user experience wrong isn't just a conversion problem.

Best for: HealthTech startups building patient-facing products, MedTech companies developing hardware-integrated software, and healthcare organisations seeking design-led product engineering.

Healthcare capabilities:

• Patient-facing mobile applications for chronic condition management, women's health, and remote monitoring

• Hardware and wearable integrations for real-world clinical data collection (including Apple Watch/HealthKit)

• End-to-end product delivery: from clinical user research and discovery through to regulated, production-ready software

• Data-led health platforms combining behavioural tracking with clinical evidence requirements

Compliance & security: Secure-by-design delivery with zero-trust architecture, MFA, and data encryption at rest and in transit. Familiar with GDPR requirements and the clinical evidence standards expected under MDR.

Proof points:

• Lyv — a holistic app for endometriosis care, developed through deep clinical user research

• Emm — a smart menstrual cup and companion data app for a biotech startup

• Merck — a lightweight diabetes risk assessment app (0.7 MB) optimised for low-connectivity environments

• Convatec — iOS/Apple Watch integration for HRV data collection in clinical trials

Typical engagement: Most projects start with a discovery workshop and product design sprint before moving into iterative development. Monterail works with both early-stage teams building from scratch and established companies extending or rebuilding existing products.

Why they made this list: Their healthcare portfolio is publicly documented and spans genuinely different problem spaces — from women's health and wearables to clinical trials and diabetes management — which is a more reliable signal than a dedicated healthcare page with no named clients behind it.

ELEKS (Ukraine / Estonia)

ELEKS has been building custom software since 1991, which puts them in a different category from most agencies on this list in terms of sheer delivery experience. They have offices across Europe — including Estonia, Poland, and Germany — and a healthcare practice that's been developed over many years rather than assembled quickly to follow market demand.

Best for: Medical device software, EHR/EMR development, healthcare cybersecurity, and organisations that need a structured, compliance-first delivery partner.

Healthcare capabilities:

• Full-cycle development for patient experience platforms, including journey blueprinting and systems integration

• Custom EHR/EMR solutions and interoperability work across disparate health systems

• Dedicated cybersecurity services — vulnerability assessments, penetration testing, managed security

• Proof-of-concept development for emerging medical technologies

Compliance & security: ISO 27001 certified, experienced with GDPR requirements and the clinical evidence standards expected under MDR.

Proof points:

• WellAir — mobile app and GUI for a medical-grade air disinfection system, delivered on a fixed-price budget under tight timeline constraints

• Fleming-AOD — cross-platform remote patient assessment tool, built in four weeks at 80% lower development cost than the client's initial estimate

Typical engagement: Structured phases from requirement definition and prototyping through to delivery and ongoing support. Suits both defined-scope projects and longer partnerships.

Why they made this list: Long track record, genuine compliance depth, and healthcare case studies that are specific enough to be useful.

N-iX (Ukraine / Poland)

N-iX has been around for over 20 years and has grown into one of the larger engineering companies in Central and Eastern Europe, with offices in Poland, Sweden, and Ukraine. They work across a range of industries, including healthcare and life sciences. 

Best for: Healthcare platform engineering, large-scale system integrations, life sciences data platforms, and organisations modernising clinical infrastructure.

Healthcare capabilities:

• Development of healthcare platforms, patient portals, and clinical data management systems

• HL7/FHIR interoperability and integration across disparate health systems

• Data engineering and analytics for life sciences and clinical research

• Cloud migration and modernisation of legacy healthcare systems

Compliance & security: N-iX works within HIPAA and GDPR frameworks, with secure development practices, documented QA processes, audit trails, and access governance built into their healthcare delivery.

Proof points:

• Weinmann Emergency — long-term software development partnership with a Hamburg-based medical technology company producing life-saving emergency equipment

• Clinical trial data platform — modernisation of digital solutions for a company providing software to improve clinical trial data quality and accuracy

• Think Research — software product development for a healthtech company building knowledge-based tools to help clinicians deliver better care

Typical engagement: N-iX works both as an extended team and as a full delivery partner, depending on the client's existing in-house resources. Projects typically open with a scoping phase before moving into structured delivery.

Why they made this list: The combination of engineering scale, a properly developed healthcare practice, and demonstrable experience in life sciences data makes them a credible option for larger or more complex projects.

Sigma Software (Ukraine / Sweden)

Sigma Software is part of the larger Sigma Group, a Swedish technology company, which gives them an interesting position on this list: Eastern European engineering depth combined with Nordic delivery culture and corporate backing. 

Best for: Custom healthcare software, medical device software development, organisations looking for a partner with both strong engineering capacity and Western European corporate standards.

Healthcare capabilities:

• Development of patient-facing applications, clinical decision support tools, and hospital management systems

• Medical device software and embedded systems development

• Healthcare data management, analytics, and system integrations

• Telehealth and remote patient monitoring platforms

Compliance & security: Sigma Software works within ISO 13485, IEC 62304, and GDPR frameworks. Their connection to the Sigma Group brings additional quality management infrastructure and corporate-level security practices.

Proof points:

• CGM — Information security audit — conducted an information security maturity assessment and built an application security framework based on OWASP standards for a global medical software company

• AstraZeneca — Patient recruitment system — developed a centralised patient database and recruitment system to identify and enroll COPD patients into clinical studies for one of the world's largest pharmaceutical companies

• Siemens Healthineers — CT monitoring platform — joined a multi-vendor project to migrate Siemens' CT scanner monitoring platform to Azure Cloud, working alongside Microsoft and Databricks

Typical engagement: Sigma Software works both as a dedicated team extension and as a full delivery partner. Their Swedish roots make them particularly well-suited for clients who need nearshore European delivery with a structured, process-oriented approach.

Why they made this list: The combination of Scandinavian corporate backing, genuine med-tech client experience, and cross-border European delivery makes them a distinctive option in this space.

Andersen (Poland / Germany)

Andersen is a software development company with over 3,500 engineers and offices across Europe, including Poland, Germany, and several other locations. They've built a substantial healthcare practice with over 150 projects delivered. 

Best for: EHR/EMR development, telehealth platforms, clinical data management, and enterprise healthcare organisations that need a large, experienced team with strong compliance credentials.

Healthcare capabilities:

• Custom EHR and EMR systems, patient portals, and clinical data management platforms

• Telehealth and remote patient monitoring solutions with wearable and IoT integrations

• AI and machine learning applications for diagnostics, health data management, and workflow automation

• System integrations across EHR, LIS, RIS, and claims management platforms

Compliance & security: ISO 13485, IEC 62304, ISO 9001, and ISO 27001 certified. HIPAA and GDPR compliance built into delivery processes across all healthcare engagements.

Proof points:

• RenalWorks / RenalGenie — co-developed a white-label SaaS clinical data management platform for dialysis patients, supporting the client through ISO 13485 audit and certification

• HIPAA-compliant EHR system — built a custom EHR for primary care clinics to securely handle personal health data in compliance with HIPAA standards

• Telehealth platform — developed a full-featured telemedicine platform with EMR integration and remote patient monitoring for a US healthcare institution

Typical engagement: Andersen works across the full spectrum from team augmentation to end-to-end delivery, with a two-tier project management model that pairs a healthcare-experienced project manager with a delivery manager. Well suited to both greenfield builds and long-term platform evolution.

Why they made this list: A medical advisory board, four active ISO certifications, and many years of healthcare delivery add up to one of the more credibly documented healthcare practices among European software companies of their size.

Endava (United Kingdom)

Endava is a global technology services company listed on the New York Stock Exchange, with a substantial European delivery footprint spanning the UK, Romania, Bulgaria, Serbia, and beyond. They've been building software for healthcare and life sciences clients for many years, and their scale means they can handle the kind of large, multi-workstream engagements that smaller agencies can't. 

Best for: Enterprise-level healthcare modernisation, pharmaceutical R&D platforms, large-scale cloud transformation, and organisations managing complex legacy system migrations.

Healthcare capabilities:

• Clinical workflow automation using AI and machine learning

• Virtual clinical trial platforms and real-world data collection tools

• Connectivity and interoperability services for diagnostic devices and laboratory systems

• Legacy system modernisation and migration to cloud-native architectures

Compliance & security: Endava operates under an ISO 13485-certified Quality Management System, with software development aligned to IEC 62304 and both FDA and EU regulatory requirements.

Proof points:

• SOPHiA GENETICS — strengthened the technology infrastructure for the DDM™ Platform, empowering clinicians with data-driven decision tools

• Concern Health — migrated a mental wellbeing platform to AWS, improving scalability and security while implementing smart patient matching algorithms

Typical engagement: Endava typically works through augmented delivery teams and a multi-shore model, making them well-suited for long-term modernisation programmes rather than short, contained builds.

Why they made this list: One of the few companies on this list with ISO 13485 certification and the delivery infrastructure to sustain enterprise-scale healthcare programmes across multiple European markets.

How to Choose a Healthcare Software Development Partner: A Practical Checklist

Most vendor evaluation processes look the same: review the portfolio, check the team size, and compare day rates. In healthcare software, that approach will get you into trouble. The questions that matter here are more specific — and the answers reveal a lot more about whether a partner is genuinely equipped for this space or just listing it as an industry vertical.  Here's what to ask.

Healthcare Software Vendor Evaluation Checklist (Europe-Focused)

1. Which regulations apply to your product — and has the partner delivered under them before?

Start here. If you're building a patient-facing app that collects health data, GDPR applies. If your software influences clinical decisions or connects to a medical device, you're likely in MDR/IVDR territory and need a partner familiar with IEC 62304 (medical device software lifecycle) and ISO 13485 (quality management for medical devices). 

Ask candidates directly: have they shipped a product under these frameworks before? Can they show you the case study? 

General "we work in regulated industries" answers are not enough.

2. How will patient data (PHI/PII) be protected?

Don't accept "we follow GDPR" as an answer. Push for specifics: How is PHI/PII encrypted at rest and in transit? Who has access, and how is that access controlled and audited? What's the incident response plan if there's a breach? Do they have ISO 27001 certification, or an equivalent security management framework? 

The more concrete their answers, the more seriously they take it.

3. How will the system integrate with existing healthcare infrastructure?

Interoperability is one of the most underestimated complexities in healthcare software. If your product needs to connect to an EHR, a laboratory system, a hospital's legacy infrastructure, or a wearable device, ask how the partner approaches this. 

HL7 and FHIR are the standards that make healthcare systems talk to each other — a partner working in this space should be able to discuss them fluently, not just recognise the acronyms.

4. What does QA and validation look like in a regulated environment?

In standard software development, QA catches bugs. In regulated healthcare software, QA is part of the compliance evidence trail. Ask whether they maintain design history files, traceability matrices, or validation documentation. 

For SaMD (Software as a Medical Device) specifically, ask how they approach clinical safety and risk management — ISO 14971 governs this. 

If they look blank, move on.

5. How do they approach UX — for patients and for clinicians?

These are two very different user groups with different needs, contexts, and failure modes. A patient managing a chronic condition at home needs clarity and reassurance. A clinician using a decision support tool under time pressure needs speed and accuracy. 

Good healthcare software teams research both separately and design accordingly. Ask to see examples of user research conducted in healthcare contexts, not just general usability work.

6. What happens after launch?

A product launch in healthcare is not the end — it's the beginning of an ongoing responsibility. Ask about monitoring practices, SLA commitments, and how they handle incident response in production. 

Ask whether they offer roadmap support and how they manage regulatory updates that might affect your product after release. Partners who treat go-live as the finish line are partners who haven't worked in healthcare long enough.

Monterail, a Reliable Healthcare Software Development Partner

The order of profiles in this article doesn't reflect a ranking. Every company here has genuine strengths, and the right choice depends entirely on your product type, regulatory context, team setup, and timeline. 

That's precisely why we put the checklist together — use it alongside the comparison table to shortlist three to five vendors that fit your situation.

If you're building a patient-facing product, a clinician workflow tool, or a HealthTech platform and want to talk through your requirements, get in touch with us.

Why the Stakes Are Different in Healthcare Software

Software development partners are rarely interchangeable, but in most industries, a poor choice can be corrected. Vendors can be replaced, products refactored, and transition costs absorbed. In healthcare, that margin for error is significantly narrower.

When a product processes patient data, supports clinical decisions, or underpins care delivery, the stakes extend beyond budgets and timelines. The development partner you select directly influences whether the product can be:

• Trusted by clinicians and patients

• Certified under applicable regulatory frameworks

• Maintained compliance over time

• Safely scaled across health systems

This is not simply a question of feature delivery — it is a question of regulatory durability and operational responsibility.

The ten companies profiled in this article represent different strengths, price points, and specialization areas. Some are better suited to early-stage HealthTech MVP development. Others align with enterprise-scale modernization programs. Some focus on regulated medical device software. Others specialize in patient-facing digital platforms.

None is universally “best.” That is intentional. In healthcare software, a strong partner does more than deliver on time and on budget. They help you operate in a domain where failure can affect certification status, institutional trust, and patient safety. That level of accountability deserves deliberate selection.