MEDICAL DEVICE MANAGEMENT SYSTEMS AND ISO 13485 / ISO 14971 TRAINING
When medical device nonconformities occur, peoples' lives are often at stake. Consequently, the medical device industry is one of the most heavily regulated, and product and process compliance is a primary objective for all quality management systems for medical devices.
The leading organizations in the medical device industry understand that developing a process-based management system is the best approach to ensuring compliance over time. By understanding their business processes in the context of a management system, these organizations ensure the critical process controls and resources are established sufficiently to ensure the organization complies naturally through its operation. They also ensure they have a key process for identifying and deploying regulatory requirements!
Internationally, ISO 13485:2016 has been recently updated, developed, and agreed as the quality management systems for organizations producing medical devices. ISO 14971 provides the requirements for the application of risk management to medical devices. However, these minimal requirements only establish a framework for conformity and compliance, they do not guarantee it.
At QMII, we pride ourselves in our >25 years of developing process-based management systems in the medical devices industry. By focusing on process management instead of just compliance, our clients use the need to comply as the driver for also improving their business. This approach and experience is integral to our training.