QMS for Medical Devices

Industry-leading solutions for Medical Device quality and compliance management

QMS for Medical DeviceMedical Device manufacturers are faced with a wide range of quality and compliance challenges.

Compliance with UDI, eMDR, ISO 13485:2016, MDSAP, EU MDR, and other global regulations are constant requirements in a highly competitive marketplace.

Staying on top of medical device compliance is challenging enough, but new programs like the FDA’s Quality Metrics initiative are pushing the industry toward data-driven medical device quality management systems that focus on results.

No matter where you in terms of quality maturity or audit readiness, Pilgrim Quality Solutions can help. Whether you need to develop a risk-based CAPA process, ensure that your team is adequately trained and following procedures, keep suppliers under control, submit electronic medical device reports, or structure your quality system data to support quality metrics and reporting, SmartSolve® gives you integrated quality management capabilities to achieve your goals.

SmartSolve QMS Medical Device Solutions



Plan, manage, and conduct internal, supplier, and regulatory audits.

Implement a risk-based corrective and preventive action process for regulatory compliance.

Ensure consistent and compliant change throughout the organization.

Streamline complaint handling and regulatory reporting.

Build a foundation for quality and compliance.


Streamline incoming inspections based on supplier risk.

Capture, resolve, and track both supplier and internal defects.

Evaluate and manage product recalls and corrections.

Identify and focus on the suppliers that matter most.

Ensure a competent, compliant workforce.


Quality Intelligence Brings Actionable Insight

SmartSolve lets you gain insight over your quality management operations with built-in tools for monitoring key processes. You can keep tabs on trends, share reports throughout your organization, or get more hands-on with data analysis with our quality intelligence tools.

Tools to Tailor, Extend, and Integrate Quality Processes

Pilgrim’s Medical Device Quality Management System solutions are developed on SmartSolve's Platform for Compliance. SmartSolve's Platform Services, Enterprise Integration, and Configuration Tools make it easy to extend workflows and forms, integrate processes, and tailor capabilities as the demands on your quality management system for medical devices grow. Plus, Pilgrim's secure, cloud-based deployment options and automated validation tools help your team get up and running on new processes quickly.





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Learn how SmartSolve has helped a rapidly growing contract manufacturer comply with cGMP requirements.

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