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Medical Device Quality Management Solution
Leading Quality and Compliance Solutions for the Medical Device Industry
Dot Compliance delivers a comprehensive quality and compliance solution that helps medical device companies maintain control of critical processes. It manages all quality activities, including document control, CAPA, change management, supplier quality, risk management, and training. Each process is fully traceable, ensuring all data and actions are recorded in compliance with regulatory requirements.
Automation reduces manual data entry and the potential for human error, allowing teams to complete reviews, approvals, and updates more efficiently. The platform provides complete visibility across departments such as R&D, manufacturing, and regulatory affairs, ensuring that all teams are aligned around current, approved information. Real-time dashboards and analytics support better decision-making by giving quality leaders access to key metrics and insights.
By standardizing workflows and ensuring consistent execution, Dot Compliance helps organizations simplify audit preparation and maintain inspection readiness. All records are version-controlled, securely stored, and easily retrievable. The system supports validation requirements and provides an audit-ready environment that demonstrates compliance with global regulations.
Proactive Quality Management
A proactive approach to quality is critical in the medical device industry, where patient safety depends on effective risk prevention and early detection of issues. Dot Compliance helps organizations identify, track, and resolve quality events before they lead to noncompliance or product recalls. The system automates CAPA processes, linking them directly to deviations, complaints, and audit findings. This ensures that every issue is documented, investigated, and resolved according to approved procedures.
By analyzing data across the organization, quality teams can identify recurring issues and take preventive actions that strengthen overall process control. AI-driven insights highlight trends and potential risks, enabling early intervention. This reduces the likelihood of post-market issues and supports continuous improvement. With automated workflows, built-in accountability, and clear visibility into every action, medical device manufacturers can maintain compliance while minimizing risk.
Greater Supply Chain Visibility
Medical device manufacturing depends on complex global supply chains where quality issues can arise at any point. Dot Compliance provides supplier quality management tools that ensure all partners meet regulatory and internal standards. The system manages supplier qualification, audits, performance monitoring, and corrective actions in one place. Each supplier record is linked to related documentation and events, giving teams full traceability from raw materials to finished products.
This centralized approach improves control and allows teams to detect potential issues quickly. It also simplifies communication and collaboration between suppliers and internal stakeholders. When nonconformances occur, teams can log, investigate, and resolve them with complete documentation and accountability. By maintaining visibility and control across the entire supply chain, Dot Compliance helps manufacturers ensure product integrity, maintain compliance, and avoid costly production delays.
Unified Processes
Standardization across departments is essential for compliance and efficiency. Dot Compliance connects quality, regulatory, and operational processes in a single environment, ensuring that everyone works from the same validated system. This unified structure promotes consistency and improves collaboration between R&D, manufacturing, and quality teams.
Automated workflows enforce standard operating procedures and approval paths, helping organizations meet requirements from standards such as ISO 13485 and FDA 21 CFR Part 820. Changes, deviations, and training updates are tracked and linked to relevant documentation, ensuring full traceability. By integrating all quality functions, Dot Compliance eliminates silos and reduces duplication of effort.
With all data connected and accessible in real time, medical device companies can make informed decisions faster and maintain continuous compliance. This unified approach enhances operational efficiency and supports the development and delivery of safe, compliant, and high-quality medical devices to the market.
How Dot Compliance Helps
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.
