Best Medical Device Development Companies

Lemberg Solutions vs Bluefruit Software: full comparison for 2026

Quick verdict

Lemberg Solutions (4.8/5) edges ahead of Bluefruit Software (4.1/5) overall. Lemberg Solutions is the better choice for connected and smart medical devices, one engineering team. Bluefruit Software is the stronger option for UK device makers outsourcing firmware and testing. The right choice depends on your project size, budget, and required tech stack.

Lemberg Solutions vs Bluefruit Software: head-to-head summary

Criterion Lemberg Solutions Bluefruit Software
Founded 2007 2000
HQ Lviv, Ukraine (offices in Hamburg, Germany; London, UK; Kraków, Poland) Redruth, Cornwall, UK
Team size 200+ 70–90
Rating 4.8 / 5 4.1 / 5
Primary differentiator Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture
Pricing model Fixed project, time and materials, dedicated team Time and materials, fixed project
Min. engagement Not published Not disclosed
Primary tech stack Embedded Linux, RTOS, FPGA Embedded C/C++, RTOS, Test automation
Industries served Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics Diagnostics & lab devices, Surgical & therapeutic devices, Industrial

Lemberg Solutions vs Bluefruit Software: overview

Lemberg Solutions

Founded in 2007, Lemberg Solutions builds both hardware and software, and has offices in Lviv, Hamburg, London and Kraków. For medical device teams it covers electrical engineering, firmware, RTOS and embedded Linux development, FPGA programming, GUI work, connectivity and IoT, edge AI and cybersecurity, so one vendor can own the device electronics, its embedded code and the cloud or mobile side that talks to it. Healthcare is one of its core industries alongside automotive, energy and logistics, and named clients include Astronics, Caltech, Ferno, Cellink and Bosch Rexroth. The company holds ISO 27001 and ISO 9001 certification and runs its own hardware lab. It does not manufacture finished devices at volume and does not obtain regulatory clearance on a client's behalf; it supplies the engineering documentation the client's regulatory team needs.

Bluefruit Software

Bluefruit Software has written embedded software from Redruth, Cornwall, since 2000 and is employee-owned. A Plymouth University partnership case study reports that medical devices grew from 10% to 60% of its work. It handles embedded software development, testing, some hardware development and edge AI integration, plus support for regulatory compliance and quality assurance. Its team is roughly 70 to 90 people.

Services and capabilities: Lemberg Solutions vs Bluefruit Software

Capability Lemberg Solutions Bluefruit Software
Electronics & PCB design ✓ ✗
Firmware & embedded software ✓ ✓
SaMD & companion apps ✗ ✗
Connected devices & IoT ✓ ✗
Industrial design & human factors ✗ ✗
Mechanical engineering ✗ ✗
Device cybersecurity ✓ ✗
Regulatory & QMS support ✗ ✓
Manufacturing & scale-up ✗ ✗

Tech stack comparison: Lemberg Solutions vs Bluefruit Software

Framework / platform Lemberg Solutions Bluefruit Software
Embedded C/C++ N/A ✓
Embedded Linux ✓ N/A
RTOS ✓ ✓
BLE ✓ N/A
Cloud (AWS/Azure) ✓ N/A
IEC 62304 N/A ✓
ISO 14971 N/A N/A
ISO 13485 QMS N/A N/A
Qt N/A N/A

Pricing comparison: Lemberg Solutions vs Bluefruit Software

Criterion Lemberg Solutions Bluefruit Software
Minimum engagement Not published Not disclosed
Engagement models Consulting, Dedicated team, Fixed project, Time & materials Fixed project, Time & materials
Rate transparency Not public Not public
Price tier Mid-market Mid-market

Target audience comparison: Lemberg Solutions vs Bluefruit Software

Dimension Lemberg Solutions Bluefruit Software
Best company size Startup to mid-market Startup to mid-market
Best industries Wearables & remote monitoring, Diagnostics & lab devices, Digital health Diagnostics & lab devices, Surgical & therapeutic devices, Industrial
Best use cases Building a connected wearable or home-monitoring device with a companion app and cloud backend, Adding edge AI or computer vision to an existing diagnostic instrument Writing IEC 62304 firmware for a UK device startup, Independent verification of an existing device's embedded software
Typical project type Consulting Fixed project

Lemberg Solutions vs Bluefruit Software: pros and cons

Lemberg Solutions
+ A single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs
+ Partnerships with NXP, Microchip and STMicroelectronics give early access to silicon support and reference designs
+ ISO 27001 and ISO 9001 certified, with security designed into the product rather than bolted on before release
+ In-house electronics lab shortens prototype loops and lowers R&D risk before a design freeze
+ All intellectual property transfers to the client, and the cooperation model can be consulting, team extension or full product development
+ Practical edge AI and computer vision experience for devices that need on-board inference
- No in-house mass production, so a separate contract manufacturer is needed once the design is ready to scale
- Does not obtain FDA or CE certification for clients; it provides technical documentation and engineering support for the client's own submission
- Not ISO 13485 certified per the information reviewed, so buyers should confirm how it works inside their own medical QMS
Bluefruit Software
+ Medical devices make up most of its work, so regulated firmware practice is routine
+ Strong emphasis on testing and test automation
+ Lower rates than Cambridge or London consultancies
+ Employee ownership
- Limited hardware design compared with full product development firms
- Small team; large multi-year programs may need extra partners
- No industrial design, mechanical engineering or manufacturing

Who should choose Lemberg Solutions?

A typical fit: building a connected wearable or home-monitoring device with a companion app and cloud backend.

Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics.

Who should choose Bluefruit Software?

A typical fit: writing IEC 62304 firmware for a UK device startup.

Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture. Minimum engagement is not publicly disclosed. Works best with clients in Diagnostics & lab devices, Surgical & therapeutic devices, Industrial.

Decision matrix: Lemberg Solutions vs Bluefruit Software

Your situation Recommended choice
You need full-ownership delivery on a defined project scope Lemberg Solutions
You need a large dedicated team for an ongoing programme Lemberg Solutions
Your budget is at the lower end Compare: Lemberg Solutions (Not published) vs Bluefruit Software (Not disclosed)
You need specialist depth in a specific vertical Lemberg Solutions
You need staff augmentation or team extension Neither; consider alternatives that offer staff aug
You need consulting before committing to a build Both may offer discovery engagements

Use case fit: Lemberg Solutions vs Bluefruit Software

Use case Lemberg Solutions fit Bluefruit Software fit Winner
Building a connected wearable or home-monitoring device with a companion app and cloud backend Strong Limited Lemberg Solutions
Adding edge AI or computer vision to an existing diagnostic instrument Strong Strong Both equally
Writing IEC 62304 firmware for a UK device startup Limited Strong Bluefruit Software
Independent verification of an existing device's embedded software Limited Strong Bluefruit Software

Verdict: Lemberg Solutions vs Bluefruit Software

Lemberg Solutions (4.8/5) is the stronger overall choice for most Medical Device Development projects. Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together.

Bluefruit Software (4.1/5) is worth a look if you need independent verification of an existing device's embedded software. If your situation matches that, Bluefruit Software is a competitive option.

Related comparisons

Lemberg Solutions vs Bluefruit Software FAQ

Is Lemberg Solutions better than Bluefruit Software?

Lemberg Solutions (4.8/5) scores higher overall, but "better" depends on your use case. Lemberg Solutions's strongest advantage: a single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs. Bluefruit Software's strongest advantage: medical devices make up most of its work, so regulated firmware practice is routine.

How do Lemberg Solutions and Bluefruit Software differ in pricing?

Lemberg Solutions uses fixed project, time and materials, dedicated team pricing. Bluefruit Software uses time and materials, fixed project pricing. Neither firm publishes a full rate card; a discovery call is required for project-specific quotes.

Which is better for enterprise: Lemberg Solutions or Bluefruit Software?

Bluefruit Software is the larger team and typically the better enterprise-scale choice. For very large programmes, verify team size and compliance coverage directly with each company before shortlisting.

What are the main differences between Lemberg Solutions and Bluefruit Software?

Lemberg Solutions's primary differentiator is: owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together. Bluefruit Software's primary differentiator is: Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture. They also differ in team size (200+ vs 70–90), minimum engagement (Not published vs Not disclosed), and primary industries served (Wearables & remote monitoring, Diagnostics & lab devices vs Diagnostics & lab devices, Surgical & therapeutic devices).

Verify all details directly with each company before making a decision.