Key Takeaways
- Achieve faster FDA clearance and market entry by selecting a development partner who holds medical device certifications like ISO 13485.
- Ensure your technical partner has verifiable experience in building specific solutions, such as EMR/EHR systems, telemedicine platforms, or AI diagnostic tools.
- Reduce the monumental stress of compliance by knowing that your development team is building HIPAA and FDA standards into the software architecture from the very first line of code.
- Understand that building medical product software is not like standard web development; it requires specialized knowledge of HL7 FHIR integration and 21 CFR Part 11 electronic signature rules.
Finding Development Partners That Transform Healthcare Innovation Into Reality
The healthcare software market is experiencing unprecedented growth, projected to reach $974.5 billion by 2027. Yet for every successful health tech product that reaches patients, countless others stall during development because founders partnered with the wrong development team. The difference between a compliance nightmare and a market-ready solution often comes down to one critical decision: choosing a development company that genuinely understands healthcare’s unique challenges.
Building healthcare products isn’t like developing standard software. You’re navigating HIPAA compliance, FDA regulations, interoperability standards, and the lives of real patients. A generic software shop might deliver clean code, but can they guide you through 510(k) clearance? Do they understand HL7 FHIR integration? Have they actually built software that physicians use in clinical settings?
This guide profiles seven healthcare product development companies that have proven they can deliver. These aren’t generic dev shops with a healthcare page on their website. These are firms with verifiable track records, regulatory expertise, and the battle scars that come from shipping actual medical products. Whether you’re a startup founder with a breakthrough idea or an established healthcare organization expanding your digital capabilities, this list will help you find a partner who can turn your vision into a compliant, scalable, market-ready product.
Why Your Healthcare Business Needs a Strategic Development Partner
Picture this: You’ve identified a real gap in patient care. You have clinical advisors who validate the need. You might even have early funding. But when you sit down to map out the technical requirements for your electronic health record integration, or try to architect a HIPAA-compliant data storage solution, or figure out how to get FDA clearance for your diagnostic algorithm, the complexity becomes overwhelming.
This is where most healthcare innovations stall. Not because the idea lacks merit, but because healthcare product development demands specialized expertise that internal teams rarely possess. You can’t just hire a talented developer and expect them to navigate the intricate web of healthcare regulations, security requirements, and clinical workflows.
This list represents months of research into the healthcare product development landscape. We evaluated companies based on verifiable criteria that matter for healthcare product success. We looked at years of healthcare-specific experience, because building medical software requires institutional knowledge you can’t acquire in a single project. We examined their portfolios for evidence of shipped products that real healthcare organizations use today.
The Leading Healthcare Product Development Companies You Can Trust
1. Glorium Technologies
Specialty: Full-Cycle Healthcare Product Development with Medical Device Certification
Best For: Healthcare organizations requiring FDA-ready solutions and comprehensive regulatory compliance
When most software companies claim healthcare expertise, they mean they’ve built a patient portal or two. Glorium Technologies operates in a different league entirely. With ISO 13485 certification for medical device software development, they’re one of the few firms globally equipped to handle the most regulated, mission-critical healthcare products from technical and compliance perspectives.
Founded in 2010, Glorium has spent 14 years becoming the kind of healthcare technology partner that reduces risk rather than creating it. Their portfolio reads like a comprehensive catalog of healthcare innovation. They’ve delivered 150+ healthcare products including electronic medical records and hospital management systems, AI-powered diagnostic tools and medical imaging software, telemedicine platforms and remote patient monitoring solutions, pharmacy management systems and e-prescription software, medical device software with full FDA documentation, Internet of Medical Things integrations, and AR/VR applications for physical therapy and surgical training.
What distinguishes Glorium isn’t just breadth but depth of regulatory expertise. They hold the complete stack of healthcare compliance credentials. Their ISO 13485 certification proves they maintain quality management systems specifically designed for medical device software development. They’re proficient in HIPAA and HITRUST compliance for protecting patient data, experienced with FDA 21 CFR Part 820 quality system regulations, knowledgeable in IEC 62304 for medical device software lifecycle processes, and compliant with GDPR for European healthcare clients.
This regulatory foundation translates into practical advantages. When you engage Glorium for a medical device software project, they don’t just develop code. They create the complete design history file required for FDA submissions. They implement the risk management processes mandated by ISO 14971. They establish the verification and validation protocols that auditors expect to see. They architect systems with the 21 CFR Part 11 electronic signature requirements built into the authentication layer.
Their technical capabilities match their regulatory expertise. For electronic health records development, they build custom EMR/EHR systems tailored to specific medical specialties with native interoperability using HL7 FHIR standards. Their telemedicine platforms feature WebRTC-powered video conferencing with sub-200ms latency, intelligent appointment scheduling with provider availability optimization, and secure messaging systems that maintain HIPAA compliance while feeling natural to use. Their AI and machine learning implementations include computer vision models for medical imaging analysis, natural language processing for clinical documentation, and predictive analytics for patient risk stratification.
The company’s infrastructure supports global deployment at healthcare scale. Headquartered in New Jersey with development centers in Kyiv, Kraków, and Paphos, they provide follow-the-sun development that accelerates project timelines. Their 200+ person team includes specialists in healthcare IT architecture, medical device software engineering, regulatory affairs and quality assurance, clinical workflow analysis, and healthcare data security.
Glorium’s track record includes multiple industry recognitions that verify their capabilities. They’ve been named to the Inc. 5000 list of fastest-growing companies for four consecutive years (2020-2023), demonstrating sustained business growth built on client satisfaction. They’re included in the IAOP Global Outsourcing 100 for three consecutive years (2023-2025), confirming operational excellence in service delivery. They rank among Clutch’s Top 1000 Global Service Providers (2022-2024), placing them in the top 1% of over 280,000 reviewed companies. They were recognized as one of the Top 100 Medical Software Development Companies for 2025 by Techreviewer.co.
They also maintain strategic technology partnerships that enhance their service delivery. As an AWS Select Tier Partner, they architect cloud solutions using healthcare-specific AWS services like Amazon HealthLake. As a Microsoft Silver Partner, they leverage Azure for healthcare with its HIPAA-compliant infrastructure. Their Odoo Partnership enables ERP solutions for healthcare organizations, while their Stripe Partnership facilitates secure payment processing for health tech platforms.
Their proprietary CogniAgent AI platform represents a strategic advantage for clients. Built specifically for healthcare automation, it offers a no-code interface for building cognitive AI agents, integration with over 2,700 healthcare and business applications, pre-built workflows for common healthcare scenarios, and HIPAA-compliant infrastructure with audit trails. Healthcare organizations use CogniAgent to automate appointment scheduling and patient intake, process insurance claims and prior authorizations, monitor patient engagement and care plan adherence, and generate clinical summaries from unstructured data.
Client relationships at Glorium tend toward long-term partnerships rather than transactional projects. Their 99% client satisfaction rate stems from an approach that treats client success as the primary metric. They provide proactive communication with regular status updates, transparent pricing with no hidden costs or scope creep, flexible engagement models from fixed-price to dedicated teams, and ongoing support that extends beyond initial launch. Their employee Net Promoter Score of 66 indicates a team that’s engaged and committed to quality work.
2. Arkenea
Specialty: Exclusively Healthcare-Focused Custom Software Development
Best For: Healthcare startups, medical device companies, and organizations needing deep regulatory expertise
Arkenea stands apart as a company with 100% exclusive focus on healthcare technology for the past 14 years. Founded in 2011 with a team now exceeding 50 healthcare software specialists, they’ve earned recognition as Best Bespoke Healthcare Software Developer two years running. What makes Arkenea particularly valuable is their singular devotion to healthcare, meaning every team member possesses deep domain knowledge rather than generalized software experience.
3. Emids
Specialty: Digital Transformation for Healthcare Ecosystem Players
Best For: Payers, providers, biopharma, and health tech firms seeking strategic technology partnerships
Emids has spent 26 years providing digital transformation solutions across the healthcare and life sciences ecosystem. Based in Nashville with a recent innovation hub opening in Princeton, New Jersey, they serve healthcare’s most complex organizations. Their proprietary platforms include HealthConnect (a digital PaaS for building compliant cloud-connected healthcare applications), CoreLAKE (unified data management platform), and EPulseAI (generative AI platform for healthcare).
4. Iflexion
Specialty: Custom Healthcare Software with Integration Excellence
Best For: Healthcare practices and pharmaceutical companies needing custom solutions
Iflexion brings 25+ years of software development experience with 1,000+ professionals and over 2,000 completed projects. Founded in 1999 and headquartered in Denver, Colorado, they hold ISO 9001 and ISO 27001 certifications. Their healthcare work spans hospital management systems, pharmacy management software, laboratory information management systems, and practice management solutions for specialized medical practices.
5. Oxagile
Specialty: Video Streaming and Real-Time Communication for Healthcare
Best For: Telemedicine platforms and healthcare solutions requiring video conferencing capabilities
Founded in 2005 with headquarters in New York, Oxagile has served 450+ clients with particular expertise in video streaming, AdTech, and real-time communication technologies. While they work across multiple industries, their healthcare specialization focuses on telehealth video conferencing and medical imaging solutions.
6. 10Pearls
Specialty: Agile Healthcare Innovation with Global Delivery
Best For: Healthcare providers and payers seeking 24/7 development productivity
With 650+ employees and agile teams distributed globally, 10Pearls offers onshore, nearshore, and offshore outsourcing models. Founded in 1993, they provide advanced clinical innovation using generative AI, machine learning, and IoT to drive digital engineering across healthcare.
7. BairesDev
Specialty: Nearshore Healthcare Software Development
Best For: U.S. healthcare organizations seeking cost-effective, high-quality development
Headquartered in San Francisco with delivery centers across Latin America, BairesDev provides nearshore development with strong healthcare capabilities. They specialize in EHR add-ons, telehealth and remote care applications, healthcare analytics dashboards, HIPAA-compliant architectures, and IoT-based monitoring tools.
Ready to Build Your Healthcare Product?
Choosing the right development partner will define your healthcare product’s success. The companies profiled here have proven they can navigate healthcare’s unique challenges, from regulatory compliance to clinical workflow integration. They’ve shipped products that real healthcare organizations depend on daily.
At Glorium Technologies, we’ve spent 14 years becoming the healthcare development partner that de-risks your journey from concept to market. With ISO 13485 certification for medical device software, comprehensive HIPAA and FDA expertise, and 150+ healthcare products delivered, we know how to transform your vision into a compliant, scalable solution that improves patient outcomes.
Frequently Asked Questions
Which companies have experience building telemedicine and telehealth platforms?
Glorium Technologies delivers WebRTC-powered telemedicine platforms with sub-200ms latency and full HIPAA compliance, having built comprehensive telehealth solutions across their 150+ healthcare products. ScienceSoft has launched HIPAA-compliant telehealth platforms that attracted over 1,500 patients within three months. Arkenea specializes in telemedicine platforms with native iOS and Android applications. Oxagile focuses specifically on video streaming and real-time communication for healthcare, delivering scalable videoconferencing solutions with HIPAA, PHIPA/PIPEDA, and HITECH compliance. Intellectsoft has developed telemedicine applications with AI-powered symptom analysis, while Iflexion has delivered telehealth platforms for medically underserved areas.
Where can I find developers to build EHR/EMR (Electronic Health Records) systems?
Glorium Technologies builds custom EMR/EHR systems tailored to specific medical specialties with native HL7 FHIR interoperability and integration capabilities with Epic, Cerner, and Athena systems. Arkenea offers custom EHR/EMR development with specialization in complex EHR integrations and multi-tenant SaaS architectures. ScienceSoft has delivered over 150 medical IT projects including comprehensive EHR/EMR systems with advanced analytics capabilities. Intellectsoft develops electronic medical records and patient relationship management platforms, while Emids provides FHIR-enabled solutions for health records through their HealthConnect platform. These firms understand the regulatory requirements and interoperability standards essential for clinical-grade EHR systems.
Who can help me create a mental health and therapy platform?
Glorium Technologies has built comprehensive healthcare platforms spanning behavioral health with HIPAA-compliant secure messaging, video conferencing, and appointment scheduling optimized for therapy workflows. Arkenea’s healthcare-exclusive focus includes solutions for mental health providers requiring secure patient communication and documentation. Intellectsoft develops mobile health applications for chronic disease management that extend to behavioral health use cases. ScienceSoft’s telemedicine platforms support therapy sessions with secure video capabilities. When selecting a development partner for mental health platforms, prioritize firms with proven HIPAA compliance expertise, secure video conferencing capabilities, and understanding of clinical documentation requirements specific to behavioral health practices.
Which companies specialize in remote patient monitoring (RPM) software?
Glorium Technologies delivers comprehensive remote patient monitoring solutions with Internet of Medical Things integrations, real-time data collection from medical devices, and predictive analytics for patient risk stratification. ScienceSoft has created IoT-enabled platforms for physiotherapy with motion capture algorithms and developed custom medical device software connected to diagnostic equipment. BairesDev specializes in IoT-based monitoring tools with HIPAA-compliant architectures. Oxagile has built wearable-supported rehabilitation systems that demonstrate their capabilities in device connectivity. These companies understand the technical challenges of collecting, transmitting, and analyzing patient data from diverse monitoring devices while maintaining regulatory compliance and clinical-grade reliability.
I need to build a patient engagement and portal solution – who should I hire?
Glorium Technologies builds patient portals with secure messaging, appointment scheduling, test result access, and medication management while maintaining HIPAA compliance and intuitive user experiences. Intellectsoft develops patient relationship management platforms that drive engagement through personalized communication. Oxagile has created senior patient engagement portals demonstrating their ability to serve diverse patient populations. Emids specializes in digital engagement platforms for patients and providers through their HealthConnect platform. ScienceSoft’s practice management systems include integrated patient portals with billing and scheduling capabilities.


