We evaluated 50+ medical device and SaMD software development firms across FDA regulatory expertise, 510(k) and De Novo submission track record, IEC 62304 software lifecycle compliance, clinical validation rigor, and quality management system maturity — to surface the 10 software development companies best equipped to design, build, and clear FDA-regulated Software as a Medical Device (SaMD) and software-enabled medical devices for US and global markets in 2026.
Orthogonal is widely regarded as one of the most specialized FDA SaMD software development firms in the US, with a practice built entirely around building software for regulated medical devices. Their team combines software engineers, regulatory affairs specialists, and quality engineers who treat IEC 62304, FDA 21 CFR Part 820, and FDA cybersecurity guidance as first-class development requirements — not post-build compliance audits. Orthogonal has a strong 510(k) submission track record across Class II SaMD applications in diagnostics, clinical decision support, and AI/ML-enabled devices, and is particularly cited for the completeness and FDA-readiness of their Design History File documentation.
StarFish Medical is a full-service medical device development firm with deep FDA software expertise, serving health technology companies across the US and Canada. Their multidisciplinary teams encompass software engineers, regulatory specialists, mechanical engineers, and quality assurance professionals who collaborate within an ISO 13485-certified quality management system. StarFish Medical's FDA software practice covers SaMD classification, IEC 62304-compliant software development lifecycle, Design History File preparation, and 510(k) premarket notification support — backed by over two decades of cleared medical device submissions across cardiology, ophthalmology, diagnostics, and digital health.
Sunrise Labs is a New Hampshire-based medical device development firm with over 25 years of FDA-regulated software engineering experience. Their engineering team works exclusively on FDA-regulated medical device projects — providing embedded software, firmware, SaMD, and connected health application development within a structured IEC 62304 and FDA 21 CFR Part 820 quality framework. Sunrise Labs has supported numerous 510(k) clearances and PMA supplements across Class I, II, and III devices, with particular expertise in device connectivity, wireless medical devices, and cloud-connected SaMD requiring FDA cybersecurity documentation per the 2023 Refuse to Accept guidance.
Velentium is a Houston-based medical device engineering firm specializing in FDA-regulated software and firmware development for life-critical medical devices, including implantable, Class III, and PMA-pathway devices. Their team has deep experience building device software that must satisfy the most stringent levels of IEC 62304 safety classification — Class C software — where complete traceability from requirements through verification and validation is non-negotiable. Velentium's regulatory affairs practice supports full lifecycle documentation for FDA submissions, and their quality management system is built to support both 510(k) premarket notifications and PMA premarket approvals across cardiology, neurology, and patient monitoring device categories.
MedAcuity is a Massachusetts-based medical device design and development consultancy with a strong FDA software engineering practice. Their team of engineers and regulatory specialists works within an ISO 13485-certified QMS to build FDA-regulated software for diagnostic devices, surgical tools, patient monitoring systems, and digital health applications. MedAcuity's particular strength lies in human factors engineering and IEC 62366 usability validation — producing formative and summative usability studies that meet FDA's increasing expectations for HFE documentation in 510(k) submissions, particularly for software-intensive medical devices where user interface safety is a regulatory focus.
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Minnetronix Medical is a Minnesota-based medical device contract development and manufacturing organization (CDMO) with extensive FDA software engineering capabilities. Their development teams build FDA-regulated software for high-acuity medical devices — including surgical energy systems, capital equipment, and implantable device accessories — within a rigorous ISO 13485-certified quality system. Minnetronix Medical's software practice covers embedded firmware, host software, and cloud connectivity across IEC 62304 safety classifications, with in-house regulatory affairs specialists supporting 510(k) and PMA documentation and FDA correspondence management.
Softeq is a hardware and software development firm with a well-established FDA medical device software practice covering IoT-connected devices, wearables, and SaMD applications. Their medical team builds software across embedded, mobile, and cloud tiers — implementing FDA-required documentation including Software Requirements Specifications, architecture descriptions, traceability matrices, and V&V test protocols as deliverables alongside working software. Softeq's Houston headquarters serves US medical device OEMs seeking an experienced FDA software partner with full embedded-to-cloud development capabilities and ISO 13485 quality infrastructure.
Devicix is a Minnesota-based medical device development firm offering FDA-regulated software engineering within a structured design control framework. Their engineering teams specialize in embedded software, firmware, and wireless connectivity for Class I and Class II FDA-regulated medical devices — implementing IEC 62304 software development lifecycle processes and producing complete Design History File documentation. Devicix serves medical device startups and growth-stage companies seeking an experienced FDA development partner that can take a concept through verification testing, design freeze, and 510(k) submission readiness.
Bsquare Corporation is a technology solutions firm with a healthcare and medical device software practice spanning IoT device software, Windows-based medical device applications, and connected health platforms. Their development teams bring FDA regulatory awareness to embedded and application software projects — supporting IEC 62304 documentation, requirements traceability, and quality system integration. Bsquare is a practical choice for medical device manufacturers developing software for Windows-based diagnostic workstations, patient monitoring systems, and connected medical equipment requiring FDA software documentation and validation.
Greenlight Guru is the leading Quality Management System (QMS) platform purpose-built for FDA-regulated medical device companies — and a valuable partner for software development teams seeking structured FDA compliance infrastructure. While primarily a SaaS platform, Greenlight Guru's services arm provides FDA regulatory consulting, Design History File implementation support, and 510(k) submission preparation guidance specifically tailored to software-intensive medical devices. Their platform and advisory services help software development teams implement IEC 62304-aligned documentation, manage design controls, and maintain audit-ready compliance records throughout the device software lifecycle.
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