Top Medical Device Software Development Companies and How to Choose the Right One

Outsourced engineering now runs with AI in the loop. In Deloitte’s 2024 Global Outsourcing Survey of 500+ executives, 83% said they use AI as part of their outsourced services.

For a medical device company, that changes what a vendor pitch has to prove. Fast delivery helps a regulated product only when every AI-assisted change stays reviewed, traceable, and ready for an IEC 62304 audit. Proposals tend to look alike at first glance, so the deciding test is the evidence behind each one.

This guide lists the evidence to request from every vendor, the proposal red flags worth questioning, and a 4-step way to run your evaluation. It also profiles top medical device software development companies, each with medical device work you can check against your own plans.

Key Takeaways

• A vendor’s claims about medical device experience hold up only with evidence: named device projects, sample IEC 62304 records, and written rules for AI-assisted code review.
• Requesting the same evidence from every vendor turns proposals that look alike into a side-by-side comparison you can defend.
• Red flags in a proposal, such as a vague regulatory scope or no plan for third-party components, point to questions worth asking before you sign.
• Running a 4-step evaluation, from a written brief to a paid discovery phase, keeps the final decision on facts.
• This guide profiles Relevant Software, Lemberg Solutions, Vention, Velvetech, Topflight Apps, and Arkenea as top medical device software development companies with device work on record.

Evidence to Request From Every Medical Device Software Vendor

Vendor websites and pitch decks describe capabilities in similar terms. The difference shows up in documents a team can produce only after real medical device work. Request these 7 items from every candidate:

Red Flags in a Proposal and the Questions That Clear Them

A proposal shows how a team thinks before any code exists. These 5 patterns deserve a direct question:

A Single Line Item for Regulatory Work

A proposal that prices regulatory documentation as one lump at the end suggests the team writes it after the code. Ask how documentation moves through each sprint and who reviews it. A strong answer names the documents for each stage, such as requirements, risk files, and test records, and shows how they update with the build.

Estimates Without a Software Safety Class

Effort for IEC 62304 Class A and Class C software differs widely, so an estimate without a stated class rests on a guess. Ask which class the team assumed and why. A strong answer ties the class to your intended use and explains how the estimate changes if the class moves up.

Third-Party Components Without a Plan

Open-source libraries and SDKs count as SOUP under IEC 62304, and each one needs requirements, a risk review, and monitoring. Ask how the team selects, documents, and tracks these components. 

AI Speed Claims With No Review Rules

Faster delivery through AI tools helps only when every generated change goes through the same review and traceability as human-written code. Ask who approves AI-assisted changes and how the record shows it. A strong answer names a senior reviewer for each change and keeps AI use visible in the change history.

Roles Without Names on the Team Plan

Titles such as senior developer or QA engineer say little about medical device experience. Ask for the names, CVs, and past device projects of the people assigned to your work. An answer should commit a named core team and explain how the same people stay on a multi-year product.

6 Top Medical Device Software Development Companies to Vet in 2026

The table below puts the basic evidence for each company side by side: years in business, client rating, the standards they name, device work on record, and team and rate. 

Use the table to narrow the field to vendors whose standards and past work match your device, then read the profiles for the starting point, terms, and proof each team brings. Your evidence requests then go only to the teams that already fit your product.

1. Relevant Software

• Typical starting point: you have a medical device that needs connected apps, cloud, AI, and clinical integration built around it
• Team and terms: 92% senior engineers, $50 to $99/hr
• Compliance: ISO 27001, HIPAA, GDPR
• Healthcare proof: Össur measurement and ordering cut to under 5 minutes from hours; 35K+ medical records automated for AstraZeneca

Relevant Software belongs on the list of top medical device software development companies because their data, AI, and IoT specialists share one delivery team across wearables, IoMT devices, and the AI layer of a medical product. 

Since 2013, they have delivered 200+ projects, hold a 4.9 rating on Clutch, and keep 96% employee retention, so the same people stay with a device through submission and later updates. Their AI-assisted delivery pairs AI tools with senior review and cuts delivery cycles by up to 50% and bugs by up to 20%.

Solutions they can deliver:

• Wearable and companion apps for Apple Watch, Wear OS, and Fitbit
• IoMT connectivity over Wi-Fi, and LTE-M, with cloud data pipelines
• AI for diagnostics, imaging, and medical data analytics
• FHIR and HL7 integrations
• EHR and EMR integrations

2. Lemberg Solutions

• Typical starting point: your device sits at prototype stage and needs embedded software, electronics, and a cloud platform from one team
• Team and terms: 200+ engineers, $50 to $99/hr, projects from $25,000
• Compliance: ISO 13485:2016, ISO 9001:2015, and ISO 27001:2022 certifications, with IEC 62304, MDR, FDA, and HIPAA in scope
• Healthcare proof: a saliva-sensor mouthguard prototype for Caltech and an end-to-end platform for Carepath’s edge-AI cough-monitoring device

Lemberg Solutions has built embedded systems for 15+ years and lists 10 healthcare projects in their portfolio. Their device work spans HMI, SaMD and SiMD, hardware prototyping, and PCB design, so electronics and software move forward on one plan. 

The ISO 13485:2016 certification they obtained in 2023 covers medical device software delivery, and the team reports 94% client satisfaction. Partnerships with NXP, Microchip, and STMicroelectronics support their chip-level work.

Solutions they can deliver:

• Embedded software and HMI for medical devices
• SaMD and SiMD development
• Hardware prototyping and PCB design
• Remote patient monitoring devices and platforms
• Cloud and DevOps for medical device data

3. Vention

• Typical starting point: you plan a SaMD or connected health product and need a large team that can scale with it
• Team and terms: 3,000+ engineers with 70% senior developers, $50 to $99/hr, projects from $50,000
• Compliance: ISO 27001 certification, testing to IEC 62304 and FDA requirements, and ISO 13485 expertise
• Healthcare proof: Healthera’s prescriptions app grew from 40 to 1,500 pharmacy partners during 3 years of work with the team

Vention, known as iTechArt until 2023, has delivered 200+ healthtech projects over 20+ years in business, with 100+ healthcare experts on staff. Their medical device practice covers medical device software and SaMD, with experience in FDA Class I and II products. 

A client base of 500+ companies, including 20+ that went on to IPO, gives the team long experience with products that grow fast.

Solutions they can deliver:

• Software for medical devices and SaMD
• Integration with hardware, wearables, and EHR or LIS systems
• mHealth apps for patients and clinicians
• Telemedicine applications
• QA to IEC 62304 and FDA testing requirements

4. Velvetech

• Typical starting point: your IoMT device needs an embedded UI, SaMD components, and a care platform around it
• Team and terms: 250+ specialists with 92% at middle or senior level, $50 to $99/hr, projects from $25,000
• Compliance: IEC 62304 and ISO 14971 named for SaMD work, plus HIPAA and SOC 2 alignment
• Healthcare proof: an embedded user interface for a smart glucometer

Since 2004, Velvetech has completed 1,000+ projects for 400+ clients, and 150+ of those projects serve healthcare. Their IoMT practice builds software components that qualify as SaMD and links connected devices to the platforms care teams use. A Microsoft partnership supports the cloud side of that work.

Solutions they can deliver:

• Embedded UI for medical devices
• SaMD components, including AI/ML-enabled functions
• Remote patient monitoring systems
• Medical billing and revenue cycle management software
• Cloud IoMT development on Azure

5. Topflight Apps

• Typical starting point: your device needs a patient-facing companion app with careful UX
• Team and terms: a team of about 40, $100 to $149/hr, projects from $50,000
• Compliance: IEC 62304 on the Joovv device app, HIPAA, and a regulatory lead with ISO 13485 submission experience
• Healthcare proof: AllHeartz’s remote therapeutic monitoring app, linked to up to 50% fewer in-person visits and up to 80% less clerical work

Topflight Apps has built healthcare apps since 2016 for clients such as Stanford Medicine, Merck, and Medable. For Joovv, the team built the companion app for light therapy devices under IEC 62304 across 2,100 hours of work. Their AI work for GaleAI helped recover $1.14M in lost revenue.

Solutions they can deliver:

• Companion apps for connected medical devices
• Remote patient and therapeutic monitoring apps
• AI and computer vision features
• AI support for medical coding and claims
• EHR and EMR integrations

6. Arkenea

• Typical starting point: you need a SaMD or companion app with regulatory documentation built in from the start
• Team and terms: 50+ staff, $50 to $99/hr, projects from $50,000
• Compliance: IEC 62304 safety classification, ISO 14971 risk analysis, FDA requirements, and HIPAA
• Healthcare proof: ORLink, a surgical preference card app that raised $1M+ in venture capital after launch, and NPHub, which reached $1.6M in revenue within 18 months

Arkenea has worked only in healthcare since 2011, starting with a core team of 6, and lists 19 healthcare projects in their case studies. Their medical device service covers embedded software, SaMD, companion apps, V&V documentation, regulatory submission support, and post-market work. That scope lets one team carry a product from first build through updates after release.

Solutions they can deliver:

• SaMD development
• Companion apps that pair with devices over BLE or Wi-Fi
• V&V documentation and 510(k) or De Novo submission support
• Post-market support and maintenance
• Remote monitoring software for vital signs

Run a Vendor Evaluation in 4 Steps

A structured process keeps the choice on evidence. Each step narrows the field. Here are 4 steps that take you from a long list to a signed contract:

1. Write a short brief: describe your device, intended use, target markets, expected safety class, and what you already have, such as a prototype or a QMS. Send the same brief to every vendor so their answers stay comparable.
2. Request the evidence pack: ask each vendor for the 7 items from the evidence table, with a deadline that fits your timeline. Teams with device experience can answer from documents they already have.
3. Hold a technical interview: bring your engineering and quality leads to a call with the people named in the proposal. Walk through one past device project in detail, from risk file to release.
4. Start with a paid discovery phase: commission a short, fixed-scope phase that ends with requirements, an architecture outline, and a regulatory plan. You keep the documents whatever you decide next, and you see how the team works before the larger contract.

Conclusion

Choosing a medical device software partner is a regulatory decision as much as a technical one. The team you hire produces the records your submission depends on, and they stay with the product through every update after launch.

This week, you can send one brief and one evidence request to the top medical device software development companies on your list. The answers quickly show which teams have done this work before, and the discovery phase confirms it before you commit to the full build.