Best Medical Device Development Companies

Softeq

Houston engineering company whose hardware and embedded practice holds ISO 13485 for medical work

Founded 1997 | Houston, TX, USA | 250–500 employees
electronicsfirmwareconnected-iotsamd

What is 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.

Softeq works primarily with clients in Wearables & remote monitoring, Digital health, Consumer electronics, Industrial sectors. Its primary differentiator is: Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place.

Softeq tech stack and services

PCB designEmbedded LinuxRTOSBLEiOSAndroidCloud (AWS/Azure)
Service area
Electronics & PCB Design
Firmware & Embedded Software
Connected Devices & IoT
Software as a Medical Device

Softeq pricing

Short answer: Softeq 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
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
Softeq does not publish a public rate card. Contact them directly via their website to get project-specific pricing.

Softeq pros and cons

Advantages Things to consider
+Covers hardware, firmware, apps and cloud for connected devices -Generalist firm where medical is one market among many
+ISO 13485 certification -Few public medical device case studies
+Long company history since 1997 -No industrial design or manufacturing
+Flexible engagement models including dedicated teams

Softeq vs alternatives

How Softeq compares to the other top Medical Device Development companies.

Company Best for Key difference Rating Compare
Lemberg Solutions Connected and smart medical devices, one engineering team. Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together 4.8 Full comparison
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
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

Softeq FAQ

What is Softeq?

Houston engineering company whose hardware and embedded practice holds ISO 13485 for medical work

How much does Softeq charge?

Softeq 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 Softeq use?

Softeq works with PCB design, Embedded Linux, RTOS, BLE, iOS, Android, Cloud (AWS/Azure). Primary industries served include Wearables & remote monitoring, Digital health, Consumer electronics, Industrial.

Is Softeq right for enterprise?

Connected devices needing hardware plus apps. 250–500 team size. Key consideration: Generalist firm where medical is one market among many.

What are the best Softeq alternatives?

The best alternatives to Softeq depend on your use case. Top options are:

  • Lemberg Solutions: owns pcb design, firmware, embedded linux, iot backend and edge ai under one roof, so device and cloud are designed together
  • 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
See full alternatives list

Compare Softeq with other Medical Device Development companies

Verify all details directly with Softeq before making a decision.