MasterControl’s digital ISO 13485 toolkit provides users with a simple and effective method for participating in risk assessment and mitigation activities and sets triggers to perform risk analysis. The MasterControl solution also offers supplier management features for tracking supplier agreements and risk-based control of outsourced products as well as automating the assignment and monitoring of training tasks and course completions. It provides automated routing, escalation, approval and delivery of standard operating procedures (SOPs) for effective ISO 13485 document control. The MasterControl quality control management suite is an integrated, configurable and easy-to-use software solution designed to help device manufacturers facilitate compliance to the latest ISO 13485 standard.
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