Digital Health Solutions

What Digital Health Solutions does

Digital Health Solutions (DHS) is a privately held MedTech consulting and engineering services firm headquartered in Andover, Massachusetts, with a hybrid delivery model combining Boston-based regulatory and systems engineering experts with India-based software and firmware engineering talent. Founded in 2019 with approximately 32 employees, the firm serves medical device startups and established medical device companies developing Class II and III devices, including connected wearables, SaMD, neuromodulation implants, and remote patient monitoring systems.

The company's service portfolio spans six integrated pillars: end-to-end product development, firmware and software engineering (aligned with IEC 62304), cybersecurity (aligned with FDA Premarket Guidance and SBOM requirements), systems engineering (requirements through DHF creation), quality and regulatory support (FDA 21 CFR Part 820, CE marking, FDA submissions), and ISO 13485-certified contract manufacturing. Underlying technology competencies include embedded firmware (C, C++, Keil, RTOS, Linux), iOS and Android mobile development (including Samsung Knox kiosk mode), secure web and cloud development on AWS and Azure with HiTRUST and HIPAA compliance, IoT platform development, HL7/FHIR-based EHR integration, and Machine Learning/AI validation services. The firm holds its own ISO 13485 certification and supports clients in obtaining the same, with additional compliance infrastructure covering IEC 62304, ISO 14971, FDA cybersecurity guidance, and CE marking requirements.

DHS operates a B2B professional services go-to-market model with three engagement structures: Time and Materials (hourly billing), Fixed Price for defined-scope projects, and Staff Augmentation for embedded engineers. Sales is driven through direct enterprise engagement, a website with detailed service pages, published case studies, client testimonials, and a LinkedIn presence. Customers include digital health startups such as Neuroglee Health, NanoDx, and Riva Health, alongside enterprise engagements with a global medical device leader and a Class III neuromodulation developer. No external funding rounds, M&A activity, or patent portfolio are disclosed.

Name

Digital Health Solutions

Legal name

Digital Health Solutions

Website

https://digitalhealthsol.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

Digital Health Solutions is a US MedTech consulting firm that provides end-to-end product development, firmware and software engineering, cybersecurity, regulatory, and ISO 13485 manufacturing services to medical device startups and established device companies, delivered via Boston and India teams.

Ownership category

akta.pro rank

Product category

MedTech Engineering & Regulatory Consulting Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Health Services (8000)

akta.pro primary industry

Governance, Risk & Compliance (GRC) + HIPAA/HITRUST/ISO Readiness (HLACAJAJ)

akta.pro secondary industries

Connected Medical Devices & Wearables (Sensors, Patches, Implantables) (HLACAPAB), Medical Device Connectivity & Interoperability Middleware (MDI, EHR/HL7/FHIR Integration) (HLACAPAJ)

Keywords

• Medical device consulting
• Regulatory compliance services
• Firmware engineering services
• Medical device cybersecurity
• FDA submission support

Headquarters

HQ city

Andover

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Professional Services - Time and Materials: Consulting services where clients pay an agreed hourly rate for developers and project managers. Allows flexibility in team size and workload balance.
2. Professional Services - Fixed Price: Fixed price engagement for well-defined projects with documented scope and requirements. Provides on-time, on-budget delivery with phased approach including advanced development, design, verification, and design transfer.
3. Staff Augmentation: Providing skilled engineers offshore and onsite depending on client needs. Client supervises project and technical management while DHS engineers work under client's quality system and design control process.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Digital Health Solutions provides end-to-end engineering, regulatory, and manufacturing services for medical device and digital health companies. The company develops compliant hardware, firmware, and software for Class II and III medical devices aligned with ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR Part 820, and CE marking requirements, covering the full lifecycle from concept through commercialization, including cybersecurity, systems engineering, FDA/CE submissions, and ISO 13485-certified contract manufacturing.

Product overview

Digital Health Solutions is a MedTech services company offering a comprehensive portfolio of six integrated service pillars for medical device development: Product Development (hardware, firmware, software), Firmware & Software Engineering (IEC 62304 compliant), Cybersecurity (FDA-aligned), Systems Engineering (requirements to DHF), Quality & Regulatory Support (FDA/CE), and ISO 13485 Contract Manufacturing. The company operates across the full device lifecycle from concept through commercialization, providing end-to-end engineering, regulatory, and manufacturing services. Their service offerings are supported by specialized sub-services including IoT platform development, EHR integration via HL7/FHIR, Machine Learning & AI services, and post-market surveillance capabilities. The company leverages engineering teams in Boston, MA and India to provide cost-effective consulting.

Differentiator

Problem solved

Functional benefit

Products and services

• End-to-End Product Development End-to-end product development services for medical devices from concept to commercialization, including compliant hardware, firmware, and software development aligned with ISO 13485, ISO 14971, and FDA design controls. Targeted at medical device startups and established medical device companies.
• Firmware & Software Engineering End-to-end firmware and software development aligned with IEC 62304 and SDLC best practices for medical devices, including embedded systems, cloud integration, SaMD, mobile (iOS/Android with Samsung Knox), web applications on AWS/Azure with HiTRUST certification, HL7/FHIR EHR integration, ML/AI validation, automated unit testing, and software documentation to support regulatory submissions.
• Cybersecurity Services End-to-end cybersecurity services for medical devices aligned with FDA Premarket Guidance, SBOM requirements, and secure SOUP management. Covers threat modeling, security risk assessment (cFMEA), penetration testing, vulnerability scanning, SBOM management, and post-market cybersecurity surveillance for connected and software-driven medical devices.
• Systems Engineering Systems engineering support from requirements definition and traceability through Design History File (DHF) creation, labeling/IFU, and technical leadership, aligned with ISO 14971, FDA guidance, and CE marking requirements to deliver regulatory-ready medical device product development.
• Quality & Regulatory Support Quality and regulatory support aligned with FDA 21 CFR Part 820, CE marking, and global standards, including FDA submissions (510(k), De Novo), Letter to File, Clinical Decision Support Tools, Gap Analysis, CAPA, Risk Management, SOP development, QMS design and implementation, post-market surveillance, and Quality Assurance testing for medical device clients.
• ISO 13485 Contract Manufacturing ISO 13485:2016-certified contract manufacturing for medical devices from pilot builds to full production, including tool validation, computer system validation (CSV), supply chain management, and engineering project management (planning, budgeting, scheduling, risk mitigation). Available to startups and established medical device companies.

Quantifiable outcome

• Successfully helped multiple clients achieve ISO 13485 certification
• +2 more outcomes

Named customers8 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability1 record

Feature25 records

Scale indicators1 record

Recent moves5 records

Expansion highlights5 records

Direct peers

• Velentium: Specialized medical device engineering and cybersecurity firm offering firmware, software, and FDA-aligned cybersecurity services. Almost identical six-pillar positioning to DHS, including IEC 62304, ISO 13485, and FDA premarket cybersecurity expertise, making it the closest direct comparable.
• Sunrise Labs: Medical device engineering services firm providing product development, V&V, and regulatory support for Class II and III devices. Comparable on end-to-end product development, firmware/software, and FDA submission support for MedTech clients.
• RND Group: Medical device engineering and regulatory services firm offering software development, systems engineering, and FDA submission support. Comparable on regulated software engineering and end-to-end MedTech product development services.
• StarFish Medical: Medical device design, engineering, and contract manufacturing services firm. Comparable on full-lifecycle medical device development, ISO 13485 contract manufacturing, and regulatory services for MedTech startups and established companies.
• MedAcuity: Medical software engineering services firm focused on regulated software development for medical device and digital health companies. Directly comparable in software engineering, SaMD development, and IEC 62304 compliance services for MedTech clients.
• Proxima Clinical Research: MedTech-focused CRO and regulatory consulting firm supporting FDA submissions, clinical strategy, and quality systems. Overlaps with DHS on regulatory services and FDA submission support for medical device and SaMD clients.

Broad incumbents

• Tata Elxsi: Global design and technology services firm with a dedicated MedTech practice covering SaMD, connected devices, and regulatory software. Comparable on regulated software, IoT, and AI/ML validation services for medical devices, with much larger bench and global delivery.
• Phillips-Medisize: Large-scale medical device contract manufacturer and design services provider (Molex). Directly comparable on ISO 13485 contract manufacturing and connected medical device development, though at far greater scale and with broader capabilities.
• NAMSA: Larger, established medical device testing, regulatory, and consulting organization with global footprint. Overlaps with DHS on regulatory strategy, V&V, and quality system services but at significantly greater scale and broader service breadth.

Emerging players

• Greenlight Guru: MedTech-focused quality management system (eQMS) and lifecycle software vendor. While DHS implements eQMS for clients, Greenlight Guru provides the underlying SaaS platform — making it an adjacent/emerging competitor in the same MedTech quality and regulatory workflow niche.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/digital-health-sol

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Digital Health Solutions