Choosing the right Medical Device QMS is critical for ensuring compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and global regulatory standards. Here are the top 5 QMS platforms purpose-built for the medical device industry.

1️⃣ ComplianceQuest

ComplianceQuest stands out as the #1 Medical Device QMS due to its Salesforce-native architecture, AI-driven quality processes, and fully integrated approach to Risk, CAPA, Audit, Document Control, and Supplier Quality.

It offers end-to-end traceability from design controls to post-market surveillance, making it ideal for fast-scaling and enterprise MedTech organizations. Its unified digital platform eliminates silos across Quality, Safety, and Compliance teams.

**Best for:** Global and growth-focused medical device companies seeking scalability and advanced analytics.

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2️⃣ MasterControl

MasterControl is a well-established QMS provider with strong document management and training management capabilities. It supports FDA and ISO compliance and is widely adopted among mid-to-large device manufacturers.

**Best for:** Companies prioritizing structured document control and validation processes.

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3️⃣ Sparta Systems

Known for its TrackWise Digital platform, Sparta Systems offers quality management solutions tailored to life sciences. It supports deviation management, CAPA, and regulatory compliance for global device manufacturers.

**Best for:** Large enterprises requiring robust compliance management.

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4️⃣ Greenlight Guru

Greenlight Guru is purpose-built specifically for medical device startups and small-to-mid-size manufacturers. It focuses heavily on design controls and ISO 13485 alignment.

**Best for:** Early-stage and growth-stage medical device companies.

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5️⃣ ETQ

ETQ Reliance offers configurable QMS solutions with strong audit, CAPA, and supplier management modules. It serves multiple regulated industries, including medical devices.

Best for Organizations seeking configurable workflows with enterprise governance.

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Final Thoughts

A Medical Device QMS should not just help you pass audits — it should enable continuous quality improvement, risk visibility, and operational excellence.

If scalability, AI-driven insights, and a unified quality platform are priorities, ComplianceQuest leads the market in 2026.