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Top 6 Medical Quality Management Systems Companies (September 2026)

As of September 2026, Latka tracks 6 medical quality management systems companies. They have combined revenues of $50.4M and employ 369 people. They have raised $16.3M and serve 250 customers combined.

Every company below sells medical quality management systems to other businesses and is ranked by its most recent annual revenue. Revenue, funding, headcount and customer figures come from CEO interviews on the Latka podcast, public company filings, and Latka estimates where a company has not disclosed a number.

What Medical Quality Management Systems Companies do

Medical Quality Management Systems (QMS) are structured frameworks that organizations use to manage and improve the quality of their products, particularly in the healthcare and medical device sectors. These systems encompass a variety of essential processes such as document control, change management, training management, nonconformance tracking, and audit management, helping organizations maintain compliance with regulatory standards. The primary use cases for QMS involve ensuring that all aspects of medical products, from design to production and post-market monitoring, meet safety and quality requirements. Common workflows include risk management assessments, corrective and preventive actions (CAPA), and regular internal audits, facilitating continuous improvement in product quality. Buyer personas typically include quality assurance managers, compliance officers, and regulatory affairs professionals, all focused on maintaining and verifying product and process integrity.

Companies
6
Revenue
$50.4M
Funding
$16.3M
Employees
369

Filters

Sorting: Highest -> Lowest

Filters

Top Medical Quality Management Systems Companies by revenue

Showing 6 of 6 companies ranked by annual revenue.

1Qualio logo
Qualio

San Francisco, California, United States

quality management software for life sciences industry

Revenue
$22M
Customers
250
Year founded
2012
Funding
$16.3M
Team size
117
2Greenlight Guru logo
Greenlight Guru

Indianapolis, Indiana, United States

Greenlight Guru is the only quality management software platform designed specifically for medical device companies, providing a cloud-based Quality Management System (QMS) that helps improve speed and efficiency while reducing risk.

Revenue
$16M
Year founded
2013
Team size
145
3Flinn.ai logo
Flinn.ai

Vienna, Austria

Flinn.ai is an AI-driven platform to automate regulatory and quality processes for MedTech companies, streamlining compliance submissions and enabling manufacturers to operate more efficiently.

Revenue
$5.2M
Year founded
2022
Team size
42
4SimplerQMS logo
SimplerQMS

København, Capital Region of Denmark, Denmark

SimplerQMS provides an Electronic Quality Management System (eQMS) specifically designed for Life Science companies. SimplerQMS is fully validated according to GAMP 5 and complies with FDA 21 CFR Part 11 and EU GMP Annex 11. SimplerQMS cloud-based solution allows organizations to work efficiently and paperlessly while complying with Life Science requirements such as GxP, ISO 13485:2016, FDA 21 CFR Parts 210, 211, 820, ICH Q10, EU MDR and IVDR, and others.

Revenue
$3.7M
Year founded
2017
Team size
34
5Grand Avenue Software logo
Grand Avenue Software

Saint Paul, Minnesota, United States

Grand Avenue provides the industry-leading quality management software solution for medical product companies. We are the affordable, scalable, and efficient quality compliant eQMS deployed by med-tech innovators and leaders around the world. Our team has extensive experience in software development, Software as a Service (SaaS) delivery, and quality compliance, specifically for the life sciences industries. We work hand-in-hand with startups, emerging growth and established companies to navigate the complex regulatory affairs (RA) and quality assurance (QA) environment. With Grand Avenue, compliance is assured, your budget is preserved.

Revenue
$2.1M
Year founded
2002
Team size
19
6Simploud logo
Simploud

Tel Aviv-Yafo, Israel

Welcome to Simploud's LinkedIn page! Follow us for company news, product updates, industry insights, and more. Simploud is a cloud-based quality management system that enables companies to manage all aspects of quality in highly regulated industries including pharma, biotech, and medical devices. Simploud is fully 21 CFR Part 11 and Annex 11 compliant. Our holistic approach allows you to manage the full quality life cycle efficiently and effectively. You can tailor Simploud to meet your company's specific quality, content, and training needs. Contact us to hear more at [email protected]

Revenue
$1.4M
Year founded
2018
Team size
12

Frequently asked questions about Medical Quality Management Systems Companies

How many medical quality management systems companies are there?

Latka tracks 6 medical quality management systems companies with reported revenue. Together they generate $50.4M in annual revenue and employ 369 people.

Which medical quality management systems company is the largest?

Qualio is the largest, with $22M in annual revenue, founded in 2012.

How much revenue does a typical medical quality management systems company make?

The average medical quality management systems company in this list makes $8.4M a year, across 6 companies with reported revenue. They serve 250 customers combined.

Who are the leading Medical Quality Management systems vendors?

Ranked by annual revenue, the leaders are Qualio, Greenlight Guru, Flinn.ai, SimplerQMS and Grand Avenue Software.

How much funding have medical quality management systems companies raised?

The 6 medical quality management systems companies tracked here have raised $16.3M in disclosed funding between them.

Related Vertical Industry Software categories

Inclusion Criteria

- Must provide document control functionalities for managing quality documentation and records. - Should include features for nonconformance reporting and corrective action processes. - Must support training management to ensure personnel understand compliance requirements and procedures. - Should offer auditing tools for performing internal audits and compliance checks. - Not just limited to documentation; must also include process management capabilities to improve overall quality. - Should allow traceability of processes and products to identify and mitigate risks effectively.