ScienceSoft
McKinney software company with an ISO 13485 certificate and a healthcare practice dating to 2005
Founded 1989 | McKinney, TX, USA | 700–800 employees
samdconnected-iotverificationcybersecurity
What is ScienceSoft?
Healthcare IT has been a ScienceSoft practice since 2005, inside a McKinney, Texas, software company that dates to 1989. The company holds ISO 13485:2016 certification for medical device software and SaMD, and it states experience preparing software for FDA clearance and CE marking (per company website; independently unverifiable). Its team is about 750. Its medical work is mostly software: SaMD, device companion apps, data analytics and medical device software testing.
ScienceSoft works primarily with clients in Digital health, Diagnostics & lab devices, Wearables & remote monitoring, Financial services sectors. Its primary differentiator is: Large, ISO 13485 certified software team with healthcare analytics and testing services.
ScienceSoft tech stack and services
.NETJavaiOSAndroidCloud (AWS/Azure)IEC 62304
| Service area |
|---|
| Software as a Medical Device |
| Connected Devices & IoT |
| Verification & Validation |
| Device Cybersecurity |
ScienceSoft pricing
Short answer: ScienceSoft 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 |
ScienceSoft does not publish a public rate card. Contact them directly via their website to get project-specific pricing.
ScienceSoft pros and cons
| Advantages | Things to consider |
|---|---|
| +ISO 13485 certification covers medical device software and SaMD | -Generalist IT company where healthcare is one of many practices |
| +Large team can staff software projects quickly | -No hardware, electronics or mechanical design |
| +Offers medical device software testing as a separate service | -FDA and CE experience claims are self-reported |
| +Competitive rates compared with US onshore software firms |
ScienceSoft vs alternatives
How ScienceSoft 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 |
| 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 |
| 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 |
ScienceSoft FAQ
What is ScienceSoft?
McKinney software company with an ISO 13485 certificate and a healthcare practice dating to 2005
How much does ScienceSoft charge?
ScienceSoft 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 ScienceSoft use?
ScienceSoft works with .NET, Java, iOS, Android, Cloud (AWS/Azure), IEC 62304. Primary industries served include Digital health, Diagnostics & lab devices, Wearables & remote monitoring, Financial services.
Is ScienceSoft right for enterprise?
SaMD and device software on a budget. 700–800 team size. Key consideration: Generalist IT company where healthcare is one of many practices.
What are the best ScienceSoft alternatives?
The best alternatives to ScienceSoft 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
Compare ScienceSoft with other Medical Device Development companies
ScienceSoft vs Lemberg Solutions ScienceSoft vs StarFish Medical ScienceSoft vs Sunrise Labs ScienceSoft vs Velentium ScienceSoft vs Cambridge Consultants ScienceSoft vs TTP ScienceSoft vs Zühlke ScienceSoft vs MedAcuity ScienceSoft vs Key Tech ScienceSoft vs Team Consulting ScienceSoft vs Minnetronix Medical ScienceSoft vs Planet Innovation ScienceSoft vs Orthogonal ScienceSoft vs S3 Connected Health ScienceSoft vs Veranex ScienceSoft vs Sagentia Innovation ScienceSoft vs Bluefruit Software ScienceSoft vs Promenade Software ScienceSoft vs Integrated Computer Solutions (ICS) ScienceSoft vs Delve ScienceSoft vs Kaleidoscope Innovation ScienceSoft vs Product Creation Studio ScienceSoft vs Simbex ScienceSoft vs Softeq ScienceSoft vs Tata Elxsi ScienceSoft vs Phillips-Medisize ScienceSoft vs Jabil Healthcare ScienceSoft vs Flex Health Solutions ScienceSoft vs Plexus
Verify all details directly with ScienceSoft before making a decision.