Lemberg Solutions
Editor's pick #1Hardware and software engineering company that builds connected medical devices from schematic to cloud
What is 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.
Lemberg Solutions works primarily with clients in Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics sectors. Its primary differentiator is: Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together.
Lemberg Solutions tech stack and services
| Service area |
|---|
| Electronics & PCB Design |
| Firmware & Embedded Software |
| Connected Devices & IoT |
| Edge AI |
| Device Cybersecurity |
| Verification & Validation |
Lemberg Solutions pricing
Short answer: Lemberg Solutions uses a fixed project, time and materials, dedicated team pricing approach. Minimum engagement is not publicly disclosed; a discovery call is required.
| Engagement model | Typical range | Best for |
|---|---|---|
| Consulting | Variable; depends on team size | Large programmes or team augmentation |
| Dedicated team | Variable; depends on team size | Large programmes or team augmentation |
| Fixed project | From not disclosed | Well-defined scope |
| Time & materials | Variable; depends on team size | Large programmes or team augmentation |
Lemberg Solutions pros and cons
| Advantages | Things to consider |
|---|---|
| +A single team covers electronics, firmware, cloud, data and AI, which cuts the hand-offs that usually slow connected-device programs | -No in-house mass production, so a separate contract manufacturer is needed once the design is ready to scale |
| +Partnerships with NXP, Microchip and STMicroelectronics give early access to silicon support and reference designs | -Does not obtain FDA or CE certification for clients; it provides technical documentation and engineering support for the client's own submission |
| +ISO 27001 and ISO 9001 certified, with security designed into the product rather than bolted on before release | -Not ISO 13485 certified per the information reviewed, so buyers should confirm how it works inside their own medical QMS |
| +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 |
Lemberg Solutions vs alternatives
How Lemberg Solutions compares to the other top Medical Device Development companies.
| Company | Best for | Key difference | Rating | Compare |
|---|---|---|---|---|
| StarFish Medical | Startups needing design plus pilot manufacturing. | Medtech-only practice that can build clinical and early commercial units in its own certified clean room | 4.6 | Full comparison |
| Sunrise Labs | Electromechanical devices, fluidics and infusion. | Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled | 4.5 | Full comparison |
| Velentium | Implantables and FDA cybersecurity submissions. | Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation | 4.5 | Full comparison |
| Cambridge Consultants | Novel technology with high technical risk. | Physicists, chemists and engineers working in one building on problems no off-the-shelf design can solve | 4.4 | Full comparison |
| TTP | Pharma device programs, inhalers and injectors. | Employee ownership plus long-running drug delivery and surgical device work for large pharma and medtech clients | 4.4 | Full comparison |
| Zühlke | European medtech firms modernizing device software. | A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program | 4.4 | Full comparison |
| MedAcuity | Device makers with hardware but no software team. | US-based, ISO 13485 certified team that does nothing but regulated device software | 4.3 | Full comparison |
| Key Tech | IVD instruments with consumables. | Designs the diagnostic instrument and its cartridge together, with human factors in the same studio | 4.3 | Full comparison |
| Team Consulting | Inhalers, injectors and human-factors-heavy devices. | Three decades of medical-only industrial design and human factors, especially for drug delivery | 4.3 | Full comparison |
| Minnetronix Medical | Electronic devices from design into US production. | Develops and then manufactures electronic medical devices in the same Minnesota medtech cluster | 4.3 | Full comparison |
| Planet Innovation | Diagnostics companies in Asia-Pacific and the US. | Diagnostics roots plus product and commercialization experience in Australia and the US | 4.2 | Full comparison |
| Orthogonal | SaMD and device companion apps. | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | 4.2 | Full comparison |
| S3 Connected Health | Pharma companies adding connectivity to drug delivery. | Combines embedded wireless engineering with patient-facing apps and data platforms for pharma programs | 4.2 | Full comparison |
| Veranex | Device design plus clinical trials and reimbursement. | One contract can cover engineering, clinical studies, regulatory strategy and reimbursement | 4.2 | Full comparison |
| Sagentia Innovation | Surgical robotics and combination products. | Medical development backed by a listed science group that also runs a regulatory consultancy | 4.1 | Full comparison |
| Bluefruit Software | UK device makers outsourcing firmware and testing. | Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture | 4.1 | Full comparison |
| Promenade Software | Small device makers needing software and security. | Pairs contract device software with its own medical cybersecurity tooling and information-sharing service | 4.1 | Full comparison |
| Integrated Computer Solutions (ICS) | Touchscreen user interfaces on medical devices. | Qt and embedded UI depth applied to regulated device software, including on QNX | 4.0 | Full comparison |
| Delve | User research and industrial design for medtech. | Design research and industrial design depth from two long-established US studios | 4.0 | Full comparison |
| Kaleidoscope Innovation | Enterprises already working with Infosys. | US medical design studio with access to Infosys engineering and digital capacity | 4.0 | Full comparison |
| Product Creation Studio | Pacific Northwest startups and lab instruments. | Small ISO 13485 studio that can follow its own quality system or the client's | 4.0 | Full comparison |
| Simbex | Sensor wearables and biomechanics research. | Biomechanics and sensor research background applied to wearable health devices | 3.9 | Full comparison |
| Softeq | Connected devices needing hardware plus apps. | Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place | 3.9 | Full comparison |
| ScienceSoft | SaMD and device software on a budget. | Large, ISO 13485 certified software team with healthcare analytics and testing services | 3.9 | Full comparison |
| Tata Elxsi | Large medtech firms offshoring sustaining engineering. | Offshore scale for verification, documentation and sustaining work on existing device portfolios | 3.9 | Full comparison |
| Phillips-Medisize | Drug delivery devices needing high-volume production. | Design, molding and assembly of drug delivery devices under one global quality system | 3.9 | Full comparison |
| Jabil Healthcare | Global production capacity for cleared devices. | Global scale, supply chain and FDA-registered production for established medical device brands | 3.8 | Full comparison |
| Flex Health Solutions | Design transfer into global contract manufacturing. | Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network | 3.8 | Full comparison |
| Plexus | Complex capital equipment needing build and sustaining. | Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment | 3.8 | Full comparison |
Lemberg Solutions FAQ
What is Lemberg Solutions?
Hardware and software engineering company that builds connected medical devices from schematic to cloud
How much does Lemberg Solutions charge?
Lemberg Solutions uses fixed project, time and materials, dedicated team pricing. Minimum engagement is not publicly disclosed. A discovery call is required to get project-specific quotes.
What tech stack does Lemberg Solutions use?
Lemberg Solutions works with Embedded Linux, RTOS, FPGA, NXP, Microchip, STMicroelectronics, BLE, Cloud (AWS/Azure), Edge AI, Computer vision. Primary industries served include Wearables & remote monitoring, Diagnostics & lab devices, Digital health, Automotive, Energy, Logistics.
Is Lemberg Solutions right for enterprise?
Connected and smart medical devices, one engineering team. 200+ team size. Key consideration: No in-house mass production, so a separate contract manufacturer is needed once the design is ready to scale.
What are the best Lemberg Solutions alternatives?
The best alternatives to Lemberg Solutions depend on your use case. Top options are:
- StarFish Medical: medtech-only practice that can build clinical and early commercial units in its own certified clean room
- Sunrise Labs: three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled
- Velentium: combines active-implantable engineering with a dedicated device cybersecurity team that prepares fda premarket security documentation
Compare Lemberg Solutions with other Medical Device Development companies
Verify all details directly with Lemberg Solutions before making a decision.