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Top 54 Healthcare Compliance Software SaaS Companies in May 2026

As of May 2026, there are 54 SaaS companies in Healthcare Compliance Software. They have combined revenues of $824.5M and employ 5.9K people. They have raised $635.5M and serve 48.8K customers combined.

Healthcare compliance software is designed to assist healthcare organizations in adhering to regulatory standards and managing compliance risks effectively. These platforms typically facilitate policy management, automate compliance processes, and support risk assessments to ensure that healthcare entities remain compliant with laws such as HIPAA and HITECH. The primary use cases for healthcare compliance software include ensuring audit readiness, mitigating risks associated with data breaches, and simplifying the management of changes to regulatory requirements. Key features often found in such software can include automated evidence collection, training management, and comprehensive reporting tools to track compliance status across the organization. Common buyers of healthcare compliance software range from compliance officers to IT professionals within healthcare institutions, all of whom require efficient tools to manage regulatory obligations. These users are typically concerned with maintaining confidentiality of patient information while ensuring compliance across various operational facets of the organization.

Companies
54
Revenue
$824.5M
Funding
$635.5M
Employees
5.9K

Filters

Sorting: Highest -> Lowest

Filters

Top Healthcare Compliance Software Companies

Showing 10 of 19 companies ranked by annual revenue.

1
Locatrix

Loganholme, Queensland, Australia

Our mission is unique, but simple! We Save Lives! Keeping people safe, while supporting efficient building management with spatially accurate floor plans, asset data, and evidence collection. Locatrix delivers a service for building management, public infrastructure, large corporate and Government with reputational risk who need emergency preparedness and training for building occupants who would benefit by having access to indoor floor plans and want to fulfil and comply with the duty of care to staff and visitors on site. The PlanStudio, PlanSafe, Emergency Services Platform (ESP), PlanSight and our API applications are spatial mapping and emergency preparedness applications that meet duty of care, employee wellness, OSHA/WH&S rules and public safety legislative requirements, unlike others who provide face to face emergency training resulting in poor attendance and therefore poor training outcomes and inadequate statutory reporting.

Revenue
$5M
Customers
-
Year founded
2008
Funding
-
Team size
45
Growth
-
2
Cognition Corporation

Lexington, Massachusetts, United States

Cognition Corporation, headquartered in Lexington, Massachusetts, specializes in product development and compliance solutions for the life sciences industries. Our solutions focus on enhancing efficiency, quality, and compliance throughout the development process. For medical device companies, Cognition offers a design controls software platform, Compass MED, that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster. For pharmaceutical companies, Cognition’s Compass BIO software suite of applications for CMC module 3 reports —specifically created for pharma, biotech, and CDMO companies—is an innovative, technically driven digital CMC software solution to help biopharmaceutical companies navigate, organize, and generate the complex data tables and reports required for data management of projects and regulatory submissions without requiring manual data transcription and extensive data integrity checking. Compass BIO supports both large molecule (biologics) and traditional small molecule products. Unlike other solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach so you can easily build relevant connections between data items, automatically create complex trace matrices and data tables, and export formatted documents instantly – offering a more efficient and integrated solution. We are shifting the data management landscape for life sciences product development from a static, document-based approach to a dynamic, information-driven approach helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.

Revenue
$4.5M
Customers
-
Year founded
1996
Funding
-
Team size
41
Growth
-
3
Orcanos

Givatyim, Israel

We Specialize in using Orcanos cloud software to help medical device, pharmaceutical, automotive, and aerospace manufacturers with their regulatory compliance. We have been particularly successful with manufacturers concerned about the cost of manual traceability management and were unhappy with the bottlenecks created using a paper-based quality system that slowed down the organization and put it at high risk. Our mission is to automate design control and quality management in ONE platform that adapts to the customer instead of the customer adapting to the software. By that, we reduce the overall cost and risk associated with regulatory compliance.

Revenue
$4.5M
Customers
-
Year founded
2015
Funding
-
Team size
41
Growth
-
4
Smartgate Solutions

Leeds, England, United Kingdom

Provider of a range of quality and compliance systems intended to manage and meet both their operational and regulatory requirements in the healthcare market. The company's range of quality and compliance systems uses a cloud-based radar enabling health care, social care, security and transport sectors to underpin operations and processes and give the necessary visibility against performance and compliance.

Revenue
$4.1M
Customers
40K
Year founded
2012
Funding
$2.2M
Team size
90
Growth
43.46%
5
Rimsys Regulatory Management Software

Pittsburgh, Pennsylvania, United States

Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software helps medtech regulatory affairs teams plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Unlike complex, color-coded spreadsheets, Rimsys centralizes regulatory information, automates submission processes, and provides visibility into product registrations, expirations, standards, and regulations. Rimsys supports a full breadth of regulatory activities in an integrated platform, helping medtech companies to better manage regulatory projects and resources, get products to market more quickly, and reduce risk of non-compliance, product recalls, and unexpected expirations. Request a demo at https://www.rimsys.io/demo. Contact us: [email protected]

Revenue
$4.1M
Customers
-
Year founded
2017
Funding
-
Team size
37
Growth
-
6
Aino Health

Stockholm, Stockholm, Sweden

Provider of health and safety management services. The company provides cloud based health and safety management services to its clients in Sweden.

Revenue
$3.8M
Customers
-
Year founded
1994
Funding
-
Team size
67
Growth
-84.29%
7
Soleran

Overland Park, Kansas, United States

Soleran is a leading provider of a cloud-based platform for integrated compliance management (ICM), specializing in healthcare. Soleran Healthcare is the market’s only fully Integrated Compliance Management (ICM) platform. Its complete suite of connected solutions “talk” to each other offering streamlined processes, actionable insights, and robust reporting all leading to greater efficiencies and a safer environment. Soleran's proprietary technology and processes help your facility save time, money, and lives. Specialties: Healthcare compliance, facility management, CRM, ERP, business process management. Other Top Applications 1. Work Orders (CMMS) 2. Asset Management 3. Environment of Care Tours 4. PCRA 5. ICRA 6. ILSM 7. Tracers 8. Fire Drills 9. Vendor Management 10. Permit Management 11. Risk Management

Revenue
$3.5M
Customers
-
Year founded
2004
Funding
-
Team size
32
Growth
-
8
Embleema

New York, New York, United States

Developer of healthcare blockchain application designed for secure sharing of medical records. The company's application permits healthcare data to be managed securely, not by a central authority, but by a group of healthcare stakeholders and its decentralized networks include patients, advocacy groups, life sciences companies, payers and care centers and it also publishes the open source code base for HIPAA compliant organizations to add nodes to the healthcare blockchain, enabling users to assemble, own and share their health data.

Revenue
$3.1M
Customers
-
Year founded
2018
Funding
-
Team size
23
Growth
77.11%
9
Evolux

Natal, RN, Brazil

Evolux is a Call Center ACD & Analytics platform built to supply the demands of medium and large Call Centers in terms of voice distribuition, monitoring and analytics. Our customers are in areas of high demand of voice contact, including health, finance and education industry. The flexibility achieved by a skilled development team and the use of industry standard protocols makes our product a major asset of our customers.

Revenue
$3M
Customers
-
Year founded
2009
Funding
-
Team size
27
Growth
-
10
Burstiq

Englewood, Colorado, United States

BurstIQ's platform and ecosystem will enable a coming transformation in the healthcare space

Revenue
$3M
Customers
10
Year founded
2015
Funding
$5.5M
Team size
29
Growth
65.88%

Inclusion Criteria

- Must facilitate the management of regulatory compliance within healthcare settings - Must offer features for policy management and risk assessment - Should provide automated functionalities for evidence collection and reporting - Must support audit preparedness and compliance tracking - Must be suitable for use by healthcare professionals, including compliance officers and IT staff - Not just a training tool; must also integrate compliance risk management capabilities