Akra
Akra is a SaaS provider of AI-powered validation infrastructure for regulated digital healthcare products (SaMD, Digital Therapeutics, connected medical devices), serving pharmaceutical, health-tech, and medical device companies with security, software, and product validation across HIPAA, GDPR, ISO, and PCI DSS frameworks.
- Company typePrivate
- Founded2022
- HeadquartersSan Rafael, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What Akra does
Akra is a SaaS provider of validation infrastructure purpose-built for regulated digital healthcare products, including Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device systems. The company sells to pharmaceutical companies, healthcare technology firms building AI-powered diagnostics and monitoring tools, and medical device manufacturers that must satisfy FDA, EU MDR, HIPAA, GDPR, ISO, and PCI DSS requirements. Headquartered at 7250 Redwood Blvd, Suite 211, Novato, California, Akra employs 51–100 people and markets itself globally while serving primarily North American operations.
The core product is Akra Suites, a cloud-agnostic validation platform composed of three modules — Security Validation, Product Validation, and Software Validation — backed by an AI Engine with real-time dashboards, a Core SDK for apps and IoT devices, an Enterprise Software Stack with plug-and-play Big Data integration, and a cloud-agnostic deployment Kernel supporting CI/CD. Additional features include EHR Intelligence for one-click insight extraction from Electronic Health Records, AI model lifecycle tracking, bias detection and mitigation, Explainable AI (XAI) documentation, and post-market surveillance for live AI models. The platform holds ISO 9001 and ISO 27001 certifications, obtained in 2025.
Akra operates an enterprise field sales and consultative go-to-market motion, with quote-based, multi-year contracts and no publicly disclosed pricing. Distribution is direct to enterprise buyers, supported by content marketing through the company's Digital Health AI Blog covering SaMD compliance and continuous AI validation. No funding rounds, acquisitions, partnerships, or named customer logos are disclosed in available source material.
Akra firmographics
Firmographics- Name
- Akra
- Legal name
- Akra
- Website
- https://akra.ai
- Company type
- Private
- Founded year
- 2022
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Akra is a SaaS provider of AI-powered validation infrastructure for regulated digital healthcare products (SaMD, Digital Therapeutics, connected medical devices), serving pharmaceutical, health-tech, and medical device companies with security, software, and product validation across HIPAA, GDPR, ISO, and PCI DSS frameworks.
- Ownership category
- akta.pro rank
Akra industry classification
Industry- Product category
- Healthcare Regulatory Software
- NAICS
- Software Publishers (513210)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Enterprise AI Governance, Risk & Compliance Platforms (Model Risk, Audit, Policies) (HDAEANAE)
- akta.pro secondary industries
- DTx/SaMD Evidence, Outcomes & Real-World Data (RWE) Platforms (HLACANAM), Model Governance, Risk & Compliance (GRC) Platforms (HDAAAKAA)
Keywords
Where Akra is headquartered
LocationHeadquarters
- HQ city
- San Rafael
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Akra business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Infrastructure, Operations
Revenue model
- SaaS Platform Subscription: Akra operates as a SaaS platform providing validation services for pharmaceutical and healthcare companies. The platform offers subscription-based access to validation infrastructure, security monitoring, and compliance management tools. Services cover SaMD, Digital Therapeutics, and connected medical device validation with compliance needs including HIPAA, GDPR, ISO, and PCI DSS.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom enterprise pricing based on scope and requirements |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
Akra product offering
Product offeringCore offering
Akra provides a SaaS validation platform called Akra Suites that enables pharmaceutical, healthcare technology, and medical device companies to develop, validate, and launch Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device products. The platform delivers AI-powered security, product, and software validation with built-in compliance management for FDA, EU MDR, HIPAA, GDPR, ISO, and PCI DSS standards, along with real-time dashboards, audit trails, and Explainable AI documentation to accelerate regulatory submissions.
Product overview
Akra is a digital health AI company offering a unified platform—Akra Suites—purpose-built for Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device validation. Akra Suites comprises three core validation modules (Security Validation, Product Validation, Software Validation) backed by AI-powered infrastructure including an AI Engine with Real-Time Dashboards, a Core SDK for Apps and Devices, an Enterprise Software Stack, and a Cloud-Agnostic Deployment Kernel. The platform is cloud-agnostic, plug-and-play, and integrates compliance management (HIPAA, GDPR, ISO, PCI DSS) across the entire product development pipeline. The company also offers AI-powered features such as EHR Intelligence for one-click Electronic Health Records insight extraction and AI-Powered Security Oversight for real-time monitoring.
Differentiator
Problem solved
Functional benefit
Products and services
- Akra Suites A cloud-agnostic SaaS validation platform purpose-built for Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device validation, encompassing security validation, product validation, and software validation modules with AI-powered monitoring, audit trail capabilities, and compliance management for HIPAA, GDPR, ISO, and PCI DSS. Designed for pharmaceutical companies, healthcare technology organizations, and medical device manufacturers.
Quantifiable outcome
- Faster submission cycles and reduced regulatory rejections
- +1 more outcomes
Companies that use Akra
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles2 records
Akra technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Feature10 records
Akra partnerships and signals
Strategic signalScale indicators2 records
Recent moves5 records
Expansion highlights2 records
Akra competitors and assessment
Company assessmentEmerging players
- Monitaur: AI governance platform providing bias monitoring, explainability and audit trail software for AI deployed in regulated industries including healthcare. Comparable to Akra's AI model validation and continuous monitoring offerings for regulated AI products.
Direct peers
- Dot Compliance: Electronic QMS purpose-built for FDA 21 CFR Part 820, ISO 13485 and EU MDR compliance in life sciences. Comparable to Akra in providing purpose-built, validation-ready infrastructure for regulated digital health products.
- ModelOp: Enterprise AI governance and model lifecycle platform with model risk management, audit and policy controls. Closely aligned with Akra's AI model validation, explainability, bias detection and continuous performance monitoring capabilities.
- ValGenesis: Validation lifecycle management software for life sciences with automated paperless validation across GxP-regulated systems. Closely comparable to Akra's SaaS validation infrastructure for regulated digital health and SaMD products.
- Qualio: Cloud-native QMS designed for life sciences startups and scaling companies, covering document control, training, and FDA/ISO compliance. Comparable to Akra in serving regulated digital health teams with a SaaS-first quality and compliance stack.
- ComplianceQuest: Cloud QMS platform built on Salesforce serving life sciences and other regulated industries with quality, compliance and supplier management modules. Overlaps with Akra on multi-framework compliance and enterprise quality infrastructure for pharma clients.
- Kneat: Electronic validation lifecycle platform for GxP/CSV in pharma and medical device manufacturers, replacing paper-based commissioning and qualification. Directly competes with Akra's pre-built validation pipelines, audit trails and computerized system validation workstreams.
- Greenlight Guru: Cloud QMS purpose-built for medical device companies, including design controls, DHF, and FDA/ISO compliance workflows. Directly competes with Akra's SaaMD Suites for SaMD/DTx validation customers in the medtech quality and compliance stack.
- MasterControl: Enterprise quality management and compliance platform serving life sciences and medical device manufacturers with validation, audit, and document control capabilities. Directly overlaps with Akra's validation infrastructure offering for regulated digital health and SaMD.
Broad incumbents
- Medidata Solutions: Broad clinical trials SaaS platform under Dassault Systèmes serving life sciences R&D with EDC, CTMS and analytics. Adjacent to Akra as both serve regulated life sciences with enterprise cloud platforms, though Medidata's center of gravity is clinical trial operations versus Akra's SaMD validation focus.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
Akra compliance and trust
Trust signalCompliance2 records
Akra financial estimates
Financial estimateRevenue estimate
Valuation estimate
Akra leadership team
Management profileNumber of profiles
Profiles3 records
Akra funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Akra 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 Akra
What does Akra do?
Akra provides a SaaS validation platform called Akra Suites that enables pharmaceutical, healthcare technology, and medical device companies to develop, validate, and launch Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical device products. The platform delivers AI-powered security, product, and software validation with built-in compliance management for FDA, EU MDR, HIPAA, GDPR, ISO, and PCI DSS standards, along with real-time dashboards, audit trails, and Explainable AI documentation to accelerate regulatory submissions.
Is Akra a public or private company?
Akra is a private company. It is classified as unknown and is currently operating.
When was Akra founded?
Akra was founded in 2022. It employs 51 to 100 people.
Where is Akra based?
Akra is headquartered in San Rafael, United States, in the North America region.
How does Akra make money?
One revenue line is on record: saaS Platform Subscription.
Who are Akra's main competitors?
Monitaur is listed as an emerging player. Direct peers are Dot Compliance, ModelOp, ValGenesis, Qualio, ComplianceQuest, Kneat, Greenlight Guru and MasterControl. Medidata Solutions is listed as a broad incumbent.
Does Akra have an API?
No public API is recorded for Akra.
What industry is Akra in?
Akra's product category is Healthcare Regulatory Software. Its primary akta.pro industry code is HDAEANAE, Enterprise AI Governance, Risk & Compliance Platforms (Model Risk, Audit, Policies), with a secondary code of HLACANAM, DTx/SaMD Evidence, Outcomes & Real-World Data (RWE) Platforms. Its NAICS code is 513210 and its SIC code is 7372.