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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

In the medical device industry, taking a proactive approach to quality management helps prevent recalls, reduces financial and reputational risks, and ensures patient safety by addressing issues before they escalate into post-market events.

Greater supply chain visibility

Achieving end-to-end visibility in the medical device supply chain ensures traceability, prevents delays, and safeguards product quality. It is key to effective supplier management, traceability, and collaboration.

Unified processes

Integrating processes across the organization ensures standardization, compliance with industry regulations, and improved communication between departments like R&D, manufacturing, and quality.

 

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.

Enterprise Xact

Customize and configure your eQMS to meet your unique quality and compliance requirements.

AI Xpert

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