1
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
- Growth
- 36.66%
Top 6 Medical Quality Management Systems (QMS) SaaS Companies in May 2026
As of May 2026, there are 6 SaaS companies in Medical Quality Management Systems (QMS). They have combined revenues of $50.4M and employ 369 people. They have raised $16.3M and serve 250 customers combined.
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.
Filters
Sorting: Highest -> Lowest
Top Medical Quality Management Systems (QMS) Companies
Showing 10 of 6 companies ranked by annual revenue.
2
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
- Customers
- -
- Year founded
- 2013
- Funding
- -
- Team size
- 145
- Growth
- -
3
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
- Customers
- -
- Year founded
- 2022
- Funding
- -
- Team size
- 42
- Growth
- -
4
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
- Customers
- -
- Year founded
- 2017
- Funding
- -
- Team size
- 34
- Growth
- -
5
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
- Customers
- -
- Year founded
- 2002
- Funding
- -
- Team size
- 19
- Growth
- -
6
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
- Customers
- -
- Year founded
- 2018
- Funding
- -
- Team size
- 12
- Growth
- 24.46%
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.