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Overview
Full Spectrum Software (FSS) provides end-to-end software development and testing services for highly regulated industries, including Medical Devices, Life Sciences, Digital Health, Robotics, IoT, and AI. It builds and tests software and systems, guiding products from concept to deployment, with a focus on thorough documentation, regulatory alignment, and project ownership from start to finish. The company leverages ISO 13485:2016, FDA-related processes, and a track record of delivering more than 450 commercial products on time and within budget, making it a trusted partner for clients requiring compliant, dependable software. Its differentiators include deep expertise in regulated domains, proven delivery reliability, and a history of pioneering AI solutions and IoT connectivity. The overarching goal is to help customers bring safe, compliant digital health and device software to market by providing complete lifecycle software development and validation services.
About Full Spectrum
Industries
Robotics & Automation
Enterprise Software
AI & Machine Learning
Healthcare
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Southborough, Massachusetts
Founded
1996
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Simplify's Take
What believers are saying
- AI adoption in MedTech accelerates real-world evidence generation and FDA approval of 171 AI devices.
- Software as a Medical Device market will grow 19% CAGR to USD 210B by 2035.
- Cloud-based medical device processing enables advanced analytics for personalized medicine and heavy AI computation.
What critics are saying
- IQ, FP Complete, and iDeliver undercut Full Spectrum with faster FDA submittals and lower fees by 9–15 months.
- AI-driven tools like TrustArc auto-generate ISO 13485 docs, eliminating Full Spectrum’s documentation value in 6–12 months.
- A single FDA audit failure citing unvalidated AI documentation could trigger license revocation and bankruptcy within 12 months.
What makes Full Spectrum unique
- Full Spectrum owns 23 years of experience and 450+ deployed medical device products.
- The company delivers thorough documentation and end-to-end project ownership for Life Sciences clients.
- Full Spectrum pioneered AI solutions and IoT integration under ISO 13485:2016 compliance standards.
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Benefits
Performance Bonus
Growth & Insights
6 month growth
↓ -1%1 year growth
↓ -1%2 year growth
↓ -1%Full Spectrum is Hiring for 4 Jobs on Simplify!
Find jobs on Simplify and start your career today
About Full Spectrum
Industries
Robotics & Automation
Enterprise Software
AI & Machine Learning
Healthcare
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Southborough, Massachusetts
Founded
1996
Full Spectrum is Hiring for 4 Jobs on Simplify!
Find jobs on Simplify and start your career today