ISO 13485 Software from MasterControl
For more than 25 years, MasterControl has been a leading provider of ISO 13485 quality system software to medical device manufacturers worldwide. Hundreds of medical device companies of all sizes around the globe use MasterControl ISO 13485 software to streamline and integrate quality processes.
MasterControl’s ISO 13485 document control capabilities allow device companies to automate the routing, escalation, approval and delivery of standard operating procedures (SOPs), policies and other compliance-critical information. The system also optimizes the management of audit and training programs as well as processes for handling quality events like nonconformances and CAPAs.
In alignment with the increased focus on validation highlighted in the revised ISO 13485:2016 standard, MasterControl provides the groundbreaking Validation Excellence Tool (VxT), an industry-first solution that enables companies required to conduct risk-based software validation to reduce validation times from months down to days or even hours.
MasterControl accelerates the realization of the full business and operational benefits of ISO certification, such as: