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Medical Device Quality Management Solution

Get life-saving medical devices to market faster with an eQMS
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Leading Quality and Compliance Solutions for the Medical Device Industry

Proactive Quality Management

A proactive quality approach is essential in the medical device industry, where patient safety relies on early detection and prevention. Dot Compliance enables teams to identify, track, and resolve issues before they escalate into noncompliance or recalls. The system automates CAPA management and connects it to deviations, complaints, and audits for complete traceability. AI-driven insights reveal trends and risks, helping teams act early and strengthen process control. With automated workflows and real-time visibility, organizations maintain compliance, minimize risk, and drive continuous improvement.

Greater Supply Chain Visibility

Medical device manufacturing relies on complex supply chains where quality risks can occur at any stage. Dot Compliance centralizes supplier quality management to ensure all partners meet regulatory and internal standards. The system manages qualification, audits, performance tracking, and corrective actions in one place, linking each supplier to related records for full traceability. This visibility helps teams detect issues early, improve collaboration, and resolve nonconformances quickly—protecting product quality, maintaining compliance, and preventing costly delays.

Unified Processes

Standardization is key to maintaining compliance and efficiency across departments. Dot Compliance unifies quality, regulatory, and operational processes in one validated system, ensuring consistency and collaboration between teams. Automated workflows enforce SOPs and approval paths, supporting ISO 13485 and FDA 21 CFR Part 820 requirements. Linked records for changes, deviations, and training create full traceability, reducing silos and duplication. With connected data and real-time access, medical device companies can make faster, informed decisions and maintain continuous compliance.

How Dot Compliance Helps

Proactive Quality Management
Don’t react to adverse events, prevent them from occurring in the first place. Dot Compliance’s eQMS helps medical device organizations take a proactive approach to quality, so you can tackle quality events before they threaten patient safety.
Quality and Compliance Enforcement Across the Entire Supply Chain
With Dot Compliance eQMS solutions, you can manage and automate your entire quality ecosystem within a single source of truth. Promote collaboration and ensure your organization and outsourced suppliers get the required visibility in real-time from early product development – design history files (DHF) and device master records (DMR), manufacturing – to post-market surveillance.
Connected Quality and Regulatory Enforcement
Dot Compliance’s cloud-based, end-to-end quality management solutions mitigate risks and ensure visibility and traceability. They integrate data from the beginning of the design cycle to manufacturing, all the way to post-market surveillance—all while ensuring compliance with regulations such as 21 CFR Part 11, 21 CFR Part 820, GMP, ISO 13485, ISO 9001, and others.

The eQMS that keeps you one step ahead 

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast – and to give you the insights to drive quality efficiently.

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Smart solutions for life sciences companies at every stage 

Meet the eQMS that evolves with you, from setting a foundation with core processes to the industry’s most sophisticated AI quality and compliance intelligence.

eQMS Xpress

Establish your eQMS foundation with a comprehensive set of ready-to-use core quality processes.

Compliance Xpand

Grow with additional modules to support cross-functional processes as your business evolves.

AI Xpert

Analyze enterprise data across any source to proactively flag quality and compliance risks.