Gartner’s 2025 survey of 632 B2B buyers found that 69% saw inconsistencies between information on a vendor’s website and what sellers told them. For a device maker, that gap makes published, checkable numbers the safer basis for choosing a software partner.
Not every vendor can back promises with figures you can trace, such as delivery counts, retention rates, certifications, and case results tied to a named client. Here you can weigh 6 top medical device software development companies against the figures they publish, the credentials they hold, and the results their cases report.
Key Takeaways
- Published figures help you compare vendors, but only when each one comes with a base, a time frame, and a named source.
- Regulatory delays and program overruns make a vendor’s delivery and documentation record worth checking in numbers.
- “Certified” and “aligned” describe different things, and the scope of a certificate can cover a single office.
- Speed and quality gains from AI-assisted work need a baseline and a clear account of human review.
- Relevant Software, DataArt, Innolitics, Orthogonal, Bluefruit Software, and Oxagile appear in this guide as top medical device software development companies, with each profile built on the figures the firm publishes.
Numbers That Frame Medical Device Software Buying in 2026
Three figures from FDA, BCG, and developer research show why vendor numbers deserve a close read:
FDA Review Time Runs Past the Goal
FDA’s MDUFA performance report for fiscal year 2025 shows that 510(k) reviews in FY2024 averaged 139 days from submission to decision. The goal for that year was 124 days, and the agency reports the goal as missed.
Each round of extra questions from reviewers adds time to that clock. Vendor figures on regulatory work, such as clearances supported or submissions prepared, tell you how often a team has already handled those questions.
Large Tech Programs Often Miss Their Targets
BCG’s November 2024 survey of more than 1,000 C-suite executives found that over two-thirds of large-scale tech programs are not expected to finish on time, within budget, or within scope. More than 60% of respondents linked the problem to the lack of an end-to-end master plan.
Device software carries the same risk, with regulatory work on top. Delivery records, such as projects completed and average engagement length, help you judge how a vendor plans and finishes long programs.
AI Tools Spread Faster Than Trust in Them
The 2025 Stack Overflow Developer Survey found that 84% of respondents use or plan to use AI tools. At the same time, 46% of developers distrust the accuracy of those tools, a larger share than those who trust them.
Many vendors now publish speed or quality gains from AI-assisted work. Those figures carry weight when the vendor also explains who reviews AI-generated code and how that review fits IEC 62304 verification.
Published Figures From 6 Top Medical Device Software Development Companies
Medical device software firms build the code, documentation, and test evidence behind regulated products, from imaging software to connected diagnostics.
This review identified 6 providers, and the table compares their headline figures, quality system status, and the public source where you can verify each claim.
| Company | Headline Figure | Quality System Status | Where to Verify |
|---|---|---|---|
| Relevant Software | 200+ projects since 2013 | ISO 27001 certified;HIPAA-compliant | Össur and AstraZeneca case studies |
| DataArt | 6,000+ engineers | ISO 13485 certified (one office) | DQS certificate; DiGA directory listing for INKA |
| Innolitics | 70+ medical devices since 2012 | ISO 13485 compliant QMS | 510(k) K202229 in the FDA database |
| Orthogonal | AI-ECG platform built in 7 months | ISO 13485 certified by BSI, valid to 2029 | BSI certificate MD 667628 |
| Bluefruit Software | About 3,500 tests for LumiraDx | Aligned with ISO 13485, not certified | LumiraDx case study |
| Oxagile | 350+ clients | ISO 27001 certified | ChestPal case study |
Relevant Software
- Founded: 2013
- Projects delivered: 200+
- Senior engineers: 92%
- Employee retention: 96%
- AI-assisted delivery: delivery cycles up to 50% faster, with up to 20% fewer bugs
Relevant Software counts among top medical device software development companies whose device work centers on wearables, IoMT, and AI features. The team delivers mobile apps for devices, data platforms in the cloud, and SaMD, under ISO 27001, HIPAA, and GDPR.
Engagements run as full-cycle builds, dedicated teams, or staff augmentation, and each one starts with a proposal covering estimates, timelines, and CVs. Senior engineers review AI-assisted work at every stage.
Cases to check:
- Össur: after the team brought Structure 3D scanning into the prosthetic ordering app, measurement and ordering dropped to under 5 minutes, down from hours.
- AstraZeneca: an AI medical affairs analytics platform processes 35K+ records automatically.
DataArt
- Founded: 1997
- Engineers: 6,000+ across 40+ locations
- Regulatory and quality experience: 20 years combined in the device practice
- ISO 13485: certified by DQS in November 2024, with scope covering one office
DataArt runs a medical device practice that combines regulatory strategy, quality systems, and software engineering in one engagement. The team covers SaMD, cybersecurity compliance, and submissions under FDA, EU MDR, IVDR, and UKCA rules.
Clients can start with a single need, such as a classification decision or documentation work, and expand from there. Processes align with IEC 62304 and ISO 14971, and AI governance follows ISO 42001.
Cases to check:
- Magnosco: software for a class IIa standalone medical device for melanoma detection, including a touchscreen interface tested for usability.
- Dr. Pfleger: the INKA app, certified as SaMD and listed as a DiGA for statutory reimbursement.
Innolitics
- Devices supported: 70+ since 2012
- AI and imaging experts: 4, including 3 PhDs and 2 MDs
- End-to-end SaMD budgets: from $250k to multiple millions in past projects
Medical imaging, DICOM, and SMART on FHIR apps sit at the center of Innolitics’ SaMD and SiMD work, which spans design, development, documentation, and validation. Clients pick project-based work, staff augmentation, or end-to-end delivery that runs through FDA clearance and maintenance.
Teams work in one- or two-week sprints, within the client’s quality system or their own ISO 13485 compliant one. Published clients include Varian Medical Systems, CIRS (now Sun Nuclear), and Retrieve Medical.
Cases to check:
- AI Metrics: AI tumor tracking software went from idea to FDA clearance in 18 months. The client’s founder credits the team with reaching clearance “3 years ahead of schedule and $4 million dollars under budget.”
Orthogonal
- Experience: nearly 15 years in medical device software
- ISO 13485: certified by BSI, certificate MD 667628 valid to 2029
- Device classes: Class I, II, and III, plus active implantables
Orthogonal covers medical device software from UX and human factors through verification and validation, with SaMD, AI-enabled device software, mobile medical apps, and cloud work in scope.
Development runs in two-week agile sprints under design controls, and verification runs alongside each sprint. Their team co-chairs the AAMI working group that develops TIR115 guidance for cloud use in medical devices. Regulatory experience spans FDA, EU MDR, UK MDR, and DiGA.
Cases to check:
- HeartSciences: a cloud-native AI-ECG integration platform built in 7 months, according to the client’s director of software engineering.
- PhysIQ: a testing framework and agile QMS guidance for an ambulatory monitoring platform that achieved FDA clearance.
Bluefruit Software
- Experience: over 25 years
- Specialists: 65+
- First MDR project: 2021
- Safety classes covered: IEC 62304 Class A, B, and C
Embedded software development and testing anchor Bluefruit Software’s medical device work, and their verification and validation team can join a larger multidisciplinary group.
Teams work to IEC 62304 for US and EU markets and align with ISO 13485 and 21 CFR 820, while stating openly that they hold no ISO 13485 certificate. Embedded AI, hardware development, and regulatory support round out the service range. Published clients include Cooper Surgical and Watson Marlow.
Cases to check:
- LumiraDx: a 12-person engineering and V&V team ran about 3,500 automated and exploratory tests on a point-of-care diagnostic platform that reached FDA authorisation, with 15,000+ instruments placed in 90 countries.
Oxagile
- Founded: 2005
- Clients: 350+
- ISO 27001: certified
Healthcare products with IoMT connectivity, HL7 interfaces, and FHIR compliance work make up Oxagile’s medical portfolio. On device projects, the team covers native mobile apps, cloud backends, security, and the documentation a regulated product needs.
Data protection runs through encryption, role-based access, and audit logging, with alignment to HIPAA and GDPR.
Cases to check:
- ChestPal: a smart stethoscope platform rebuilt with stronger BLE connectivity, a microservices backend, and full IEC 62304 and US device documentation.
Reading Vendor Numbers Without Getting Misled
Vendor figures fall into common types. Each one hides a detail you can surface with a single question.
Delivery Counts
A total such as “projects delivered” often mixes device software with web apps, internal tools, and short consulting work. The total shows scale but says little about regulated experience.
What to ask: How many of those projects were medical device software, which safety classes did they cover, and how many reached clearance or certification?
Certification Claims
“ISO 13485 certified” means an accredited body audited the quality system. “Aligned with” or “compliant with” means the vendor follows the standard without that audit. A certificate can also cover one office or one legal entity and leave out the team that would build your product.
What to ask: Which body issued the certificate, which sites and scope sit under the certificate, and what is the expiry date?
Percentage Gains
Figures such as faster delivery or fewer defects depend on a baseline. Without one, you cannot tell whether the gain came from a new method, a smaller scope, or a simpler project.
What to ask: What baseline did you measure against, on which projects, and over what time frame?
Client Results
A case result can reflect work by several partners, and the case page rarely shows who built what. Results that clients state in their own words carry more weight than a vendor’s summary.
What to ask: Which part of the product did your team build, and can we speak with that client?
Frequently Asked Questions About Medical Device Software Vendors
- Which numbers should a device maker ask for first?
Start with regulated device projects by safety class, clearances or certifications those projects reached, and the scope of any quality certificate. Team stability matters next, so ask for retention or average engagement length. Close with one client result you can verify through a reference call.
- Does a vendor’s ISO 13485 certificate matter if the manufacturer holds the quality system?
The manufacturer stays responsible for the device and the quality system, and FDA’s Quality Management System Regulation has incorporated ISO 13485 since February 2, 2026. A certified vendor shows that the vendor’s own processes passed an audit, which makes supplier controls easier. An aligned vendor can still work well under your quality system when the vendor follows your procedures.
- How can you verify a case result before signing?
Ask for a reference call with the named client and confirm which part of the product the vendor built. For US devices, the FDA 510(k) database lists clearance numbers and dates, so you can check any clearance a vendor mentions.
Final Thoughts
Numbers give you a common way to compare vendors that describe their work in very different terms. This guide shows which figures frame device software buying today, how to read the claims vendors publish, and which questions turn a headline number into evidence.
Before your first call, pick 3 figures that matter for your device, such as regulated projects delivered, certificate scope, or a client result you can verify. Request the same 3 figures from all top medical device software development companies you contact, and compare the answers side by side.
