Quality management for medical devices trial
Enable early product and process validation with collaborative quality planning
Strengthen quality while providing complete traceability for faster product acceptance and improved safety
Implement a culture of continuous quality improvement to boost issue resolution
Reduce errors and risk with a common environment for design and quality
Integrate DFMEA and PFMEA tools to help address compliance
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Bring compliance forward into the project planning and design processes. Assign quality criteria upfront to reduce failures and link designs to a managed FMEA.
Assess process risk and derive a Control Plan to manage quality characteristics and inspection in an integrated environment.
Manage a Corrective and Preventive Action (CAPA) process to resolve issues, find the root causes and define appropriate actions.
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