MedAcuity Software
MedAcuity Software is a US-based engineering services firm specializing in full-lifecycle software development, cybersecurity, and quality assurance for software-intensive medical devices, surgical robotics, life sciences, and federal mission-critical systems.
- Company typePrivate
- Founded2007
- HeadquartersWestford, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What MedAcuity Software does
MedAcuity Software is a privately held US-based engineering services firm headquartered in Westford, Massachusetts, founded in 2007, that specializes in software development for software-intensive medical devices and adjacent regulated systems. The firm delivers full-lifecycle engineering across strategic consulting, software development, quality assurance and compliance, and medical device cybersecurity, with particular depth in IEC 62304 Class C development, FDA risk mitigation, ISO 14971 risk management, and secure-by-design architectures. On top of these core services, MedAcuity offers two proprietary accelerators — Med OS Hardened Windows Enterprise and a Teleoperation Accelerator for Surgical Robotics — that serve as pre-built foundations to compress development timelines for compliant medical and robotics projects.
The company serves four primary verticals: MedTech/medical device manufacturers, life sciences companies, robotics firms (including surgical robotics), and federal mission-critical programs. Its revenue model is project-based professional services, billed through consulting engagements, full-lifecycle software development, and standalone QA/compliance work, with pricing determined by project scope and complexity rather than public rate cards. Distribution is primarily direct enterprise sales supported by thought leadership (a MedTech Podcast, insights/blog content), industry events such as the Society of Robotic Surgery Annual Meeting, and partner referrals from technology ecosystem participants including Kontron and Kinova.
MedAcuity operates as a bootstrapped private firm with no disclosed venture funding, parent company, or M&A activity. It maintains ISO 13485:2016 certification (achieved 2023) and ISO 27001:2022 certification (achieved 2025), both issued by Intertek, which together function as gating credentials for medical device and federal engagements. Recent strategic activity has emphasized ecosystem partnerships (Kontron for edge AI in medical devices, Kinova for surgical robotics) and the launch of a Federal government service line, indicating an intentional broadening of addressable market beyond core MedTech consulting.
MedAcuity Software firmographics
Firmographics- Name
- MedAcuity Software
- Legal name
- MedAcuity
- Website
- https://medacuitysoftware.com
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- MedAcuity Software is a US-based engineering services firm specializing in full-lifecycle software development, cybersecurity, and quality assurance for software-intensive medical devices, surgical robotics, life sciences, and federal mission-critical systems.
- Ownership category
- akta.pro rank
MedAcuity Software industry classification
Industry- Product category
- Medical Device Software Engineering Services
- NAICS
- Computer Systems Design and Related Services (54151), Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Health Services (8000), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Surgical Robotics & Computer-Assisted Surgery Platforms (HLAHADAF)
- akta.pro secondary industries
- Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine) (HLAHAEAL), Healthcare & Assistive Robotics (HDAAAIAC), Medical-Grade Device Connectivity & Device Management (MDM) (HLACAFAG)
Keywords
Where MedAcuity Software is headquartered
LocationHeadquarters
- HQ city
- Westford
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
MedAcuity Software business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Others
Revenue model
- Medical Device Software Development Services: Full-lifecycle software development services for medical device manufacturers, including requirements definition, architecture, development, verification, and maintenance planning. Revenue is generated through project-based professional services engagements.
- Strategic Consulting Services: Consulting engagements covering architecture assessments, EOL technology migration, legacy device modernization, planning and roadmaps, process improvement, project rescue, software system verification, technology due diligence, test automation, and FDA risk mitigation. Billed as advisory or fixed-scope project engagements.
- Quality Assurance & Compliance Services: Risk-based QA engineering, QMS compliance gap analysis and remediation, and Computer Software Assurance / Software Tool Validation services. Provided as part of software development engagements or standalone compliance engagements.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels4 records
MedAcuity Software product offering
Product offeringCore offering
MedAcuity is a US-based medical device consulting and engineering services firm that provides full-lifecycle software development, strategic consulting, quality assurance and compliance, and medical device cybersecurity for MedTech, Life Sciences, Robotics, and Federal organizations. Its teams deliver IEC 62304 Class C compliant software, FDA risk mitigation, QMS compliance support, and security hardening, supplemented by two proprietary project accelerators—Med OS Hardened Windows Enterprise and a Teleoperation Accelerator for Surgical Robotics—that reduce time-to-market for software-intensive medical and robotic systems.
Product overview
MedAcuity is a premier medical device consulting and engineering services firm offering a portfolio of interconnected service offerings. The core services consist of Strategic Consulting, Software Development, Quality Assurance & Compliance, and Medical Device Cybersecurity, which work together to address the full lifecycle of complex software-intensive medical device development. On top of these core services, MedAcuity provides specialized Accelerators including Med OS Hardened Windows Enterprise and Teleoperation Accelerator for Surgical Robotics, which are pre-built solutions designed to accelerate specific medical device development workflows. The company serves multiple industries including MedTech, Life Sciences, Robotics, and Federal sectors, combining advanced technologies with in-depth regulatory knowledge to help clients accelerate product development and mitigate risks.
Differentiator
Problem solved
Functional benefit
Products and services
- Strategic Consulting Strategic consulting engagements that deliver focused assessments and actionable plans in weeks, covering architecture, EOL technology migration, legacy devices, planning & road maps, process improvement, project rescue, software system verification, technology due diligence, test automation, and FDA risk mitigation for MedTech, Life Sciences, and Robotics clients.
- Software Development Full-lifecycle software development for regulated medical devices and robotics, including project planning & management, ideation, requirements definition, architecture & design, risk analysis & management, DevOps planning & CI/CD, test automation, verification, and maintenance planning.
- Quality Assurance & Compliance Risk-based quality assurance and QMS compliance services for medical devices, including QMS gap analysis, QMS compliance remediation, quality assurance engineering, and Computer Software Assurance / Software Tool Validation.
- Medical Device Cybersecurity Specialized cybersecurity services addressing security requirements throughout the medical device development lifecycle, including threat modeling, secure design, and regulatory-aligned security controls.
- Med OS Hardened Windows Enterprise A pre-configured hardened Windows Enterprise accelerator for medical device software development that accelerates design, development, and deployment while ensuring compliance with medical industry standards.
- Teleoperation Accelerator for Surgical Robotics A specialized project accelerator for surgical robotics projects that enables faster development and deployment of teleoperation capabilities while maintaining compliance with regulatory standards such as IEC 62304 Class C and ISO 14971.
Quantifiable outcome
- Reduced development time and risk through the use of specialized project accelerators
Companies that use MedAcuity Software
Customer profileSegments4 records
Ideal customer profiles4 records
MedAcuity Software technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
MedAcuity Software partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- KinovacoreMedAcuity is listed as a technology partner in Kinova's KIMA medical robotic arm launch ecosystem. The KIMA arm is designed for clinical environments with IEC 62304 Class C software and ISO 14971 safety compliance. MedAcuity provides software development expertise supporting Kinova's strategic evolution from assistive robotics into high-precision medical solutions.
- KontroncoreMedAcuity entered a strategic partnership with Kontron to develop next-generation healthcare systems for medical OEMs. The collaboration combines MedAcuity's medical device software, cybersecurity, and systems engineering expertise with Kontron's high-performance edge computing platforms and global manufacturing capabilities. The partnership focuses on edge AI in medical devices, secure connectivity, real-time data processing, and scalable system architectures for imaging equipment, diagnostic devices, and connected care platforms.
Scale indicators1 record
Recent moves6 records
Expansion highlights5 records
MedAcuity Software competitors and assessment
Company assessmentBroad incumbents
- Exponent: Exponent is a large engineering and scientific consulting firm with a dedicated medical device practice covering regulatory, software safety, and human factors. Comparable as a broader incumbent that overlaps with MedAcuity's regulatory and safety-critical engineering work for MedTech clients.
- Infosys Life Sciences: Infosys operates a sizable Life Sciences and MedTech engineering services practice covering regulated software development and digital health. Comparable as a large-scale incumbent competing for the same enterprise MedTech services contracts that MedAcuity targets.
- Intertek: Intertek is the same certification body that issued MedAcuity's ISO 13485 and ISO 27001 certifications; Intertek operates a large medical device advisory and assurance practice. Comparable as a regulatory/compliance services peer, though at much larger scale and with testing-led rather than software-led positioning.
- UL Solutions (formerly UL LLC): UL Solutions is a global testing, inspection, and certification firm deeply embedded in the medical device regulatory ecosystem (ISO 13485 audits, IEC 62304 advisory, cybersecurity). Comparable as an incumbent whose MedTech regulatory services portfolio overlaps with MedAcuity's compliance and risk-mitigation offerings.
- Cognizant Life Sciences: Cognizant's Life Sciences division delivers large-scale MedTech engineering, digital, and regulatory services to global medical device manufacturers. Comparable as a broad incumbent with overlapping services but at much larger scale and broader geographic footprint.
- BSI Group: BSI is a global standards, certification, and regulatory consulting firm with deep medical device standards expertise (ISO 13485, IEC 62304, ISO 14971). Comparable as an incumbent in MedTech compliance advisory, with overlapping regulatory consulting work for MedAcuity's clients.
Emerging players
- EPAM Systems: EPAM is a large IT engineering services firm with a growing life sciences and medical software practice. Comparable as a computer systems design + engineering services peer that increasingly competes for regulated MedTech software engagements.
- Nagarro: Nagarro is a global digital engineering firm with a healthcare and life sciences vertical that includes medical device software work. Comparable as an emerging player building MedTech software engineering capability that overlaps with MedAcuity's core services.
Direct peers
- Verista: Verista is a life sciences and medical device consulting + engineering services firm with strong FDA/IEC 62304 regulatory expertise, serving pharma, medical device, and digital health clients. Direct overlap with MedAcuity in regulated software development and quality/compliance services for MedTech OEMs.
- Bio-Excel: Bio-Excel is a specialist medical device regulatory affairs and software services firm with deep FDA submission and IEC 62304 experience. Closest head-to-head direct peer to MedAcuity given shared focus on medical device software compliance, verification, and validation services.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
MedAcuity Software social profiles
Digital presenceMedAcuity Software compliance and trust
Trust signalCompliance2 records
MedAcuity Software financial estimates
Financial estimateRevenue estimate
Valuation estimate
MedAcuity Software leadership team
Management profileNumber of profiles
MedAcuity Software funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
MedAcuity Software M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about MedAcuity Software
What does MedAcuity Software do?
MedAcuity is a US-based medical device consulting and engineering services firm that provides full-lifecycle software development, strategic consulting, quality assurance and compliance, and medical device cybersecurity for MedTech, Life Sciences, Robotics, and Federal organizations. Its teams deliver IEC 62304 Class C compliant software, FDA risk mitigation, QMS compliance support, and security hardening, supplemented by two proprietary project accelerators—Med OS Hardened Windows Enterprise and a Teleoperation Accelerator for Surgical Robotics—that reduce time-to-market for software-intensive medical and robotic systems.
Is MedAcuity Software a public or private company?
MedAcuity Software is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was MedAcuity Software founded?
MedAcuity Software was founded in 2007. It employs 101 to 250 people.
Where is MedAcuity Software based?
MedAcuity Software is headquartered in Westford, United States, in the North America region.
How does MedAcuity Software make money?
Three revenue lines are on record. Medical Device Software Development Services are the primary driver. The others are strategic Consulting Services and quality Assurance & Compliance Services.
Who are MedAcuity Software's main competitors?
Broad incumbents on record are Exponent, Infosys Life Sciences, Intertek, UL Solutions (formerly UL LLC), Cognizant Life Sciences and BSI Group. Emerging players are EPAM Systems and Nagarro. Direct peers are Verista and Bio-Excel.
Does MedAcuity Software have an API?
No public API is recorded for MedAcuity Software.
What industry is MedAcuity Software in?
MedAcuity Software's product category is Medical Device Software Engineering Services. Its primary akta.pro industry code is HLAHADAF, Surgical Robotics & Computer-Assisted Surgery Platforms, with a secondary code of HLAHAEAL, Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine). Its NAICS code is 54151 and its SIC code is 8000.