Effective complaint handling is not just a good business practice, but a critical compliance requirement in FDA and ISO environments.
"How-to" information for medical device companies complying with regulations standardized by the MDDs (Medical Device Directives). Access the MEDDEV-5 when developing quality and compliance processes.
MasterControl Field-Based Solutions (FBS) Customer Complaint™ is a configurable form-based process solution for documenting complaint information easily and efficiently.
The FDA requires medical device manufacturers to report any adverse events to the agency.
Address the key complaints-handling challenges of different sources, disconnected processes and an inefficient complaint process by automating and integrating your complaint handling.
The MasterControl Postmarket Excellence™ solution streamlines the capture and documentation of postmarket feedback from customer complaints and surveys to manage risk and ensure compliance.
The MasterControl Postmarket Excellence™ solution is the next generation of integrated surveillance, customer feedback and quality management processes.
Fagron is an international personalized medicine pharmaceutical company that recently started using MasterControl to improve its quality and manufacturing processes.
Medical device companies are required to conduct post-market surveillance (PMS) on their devices to maintain high product quality and safety.