Best Medical Device Development Companies

Lemberg Solutions vs Softeq: full comparison for 2026

Quick verdict

Lemberg Solutions (4.8/5) edges ahead of Softeq (3.9/5) overall. Lemberg Solutions is the better choice for connected and smart medical devices, one engineering team. Softeq is the stronger option for connected devices needing hardware plus apps. The right choice depends on your project size, budget, and required tech stack.

Lemberg Solutions vs Softeq: head-to-head summary

Criterion Lemberg Solutions Softeq
Founded 2007 1997
HQ Lviv, Ukraine (offices in Hamburg, Germany; London, UK; Kraków, Poland) Houston, TX, USA
Team size 200+ 250–500
Rating 4.8 / 5 3.9 / 5
Primary differentiator Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place
Pricing model Fixed project, time and materials, dedicated team Fixed project, time and materials, dedicated team
Min. engagement Not published Not disclosed
Primary tech stack Embedded Linux, RTOS, FPGA PCB design, Embedded Linux, RTOS
Industries served Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics Wearables & remote monitoring, Digital health, Consumer electronics, Industrial

Lemberg Solutions vs Softeq: 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.

Softeq

Houston-based Softeq Development Corporation dates to 1997 and builds hardware, embedded, mobile, web and cloud products. The company holds ISO 13485 certification, which it presents as evidence that it can build medical devices to industry rules. Medical devices are one of several markets it serves, along with consumer electronics and industrial IoT. Its team is in the 250 to 500 range.

Services and capabilities: Lemberg Solutions vs Softeq

Capability Lemberg Solutions Softeq
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 Softeq

Framework / platform Lemberg Solutions Softeq
Embedded C/C++ N/A N/A
Embedded Linux ✓ ✓
RTOS ✓ ✓
BLE ✓ ✓
Cloud (AWS/Azure) ✓ ✓
IEC 62304 N/A 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 Softeq

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

Target audience comparison: Lemberg Solutions vs Softeq

Dimension Lemberg Solutions Softeq
Best company size Startup to mid-market Startup to mid-market
Best industries Wearables & remote monitoring, Diagnostics & lab devices, Digital health Wearables & remote monitoring, Digital health, Consumer electronics
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 Connected home-use device with a mobile app, Firmware and cloud for a remote monitoring wearable
Typical project type Consulting Dedicated team

Lemberg Solutions vs Softeq: 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
Softeq
+ Covers hardware, firmware, apps and cloud for connected devices
+ ISO 13485 certification
+ Long company history since 1997
+ Flexible engagement models including dedicated teams
- Generalist firm where medical is one market among many
- Few public medical device case studies
- No industrial design 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 Softeq?

A typical fit: connected home-use device with a mobile app.

Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place. Minimum engagement is not publicly disclosed. Works best with clients in Wearables & remote monitoring, Digital health, Consumer electronics, Industrial.

Decision matrix: Lemberg Solutions vs Softeq

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 Softeq (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 Softeq

Use case Lemberg Solutions fit Softeq 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 Limited Lemberg Solutions
Connected home-use device with a mobile app Strong Strong Both equally
Firmware and cloud for a remote monitoring wearable Strong Strong Both equally

Verdict: Lemberg Solutions vs Softeq

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.

Softeq (3.9/5) is worth a look if you need firmware and cloud for a remote monitoring wearable. If your situation matches that, Softeq is a competitive option.

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Lemberg Solutions vs Softeq FAQ

Is Lemberg Solutions better than Softeq?

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. Softeq's strongest advantage: covers hardware, firmware, apps and cloud for connected devices.

How do Lemberg Solutions and Softeq differ in pricing?

Lemberg Solutions uses fixed project, time and materials, dedicated team pricing. Softeq uses fixed project, time and materials, dedicated team 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 Softeq?

Softeq 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 Softeq?

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. Softeq's primary differentiator is: Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place. They also differ in team size (200+ vs 250–500), minimum engagement (Not published vs Not disclosed), and primary industries served (Wearables & remote monitoring, Diagnostics & lab devices vs Wearables & remote monitoring, Digital health).

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