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 has been developed and agreed as the quality management system 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.
Instructor-led Training and Workshops:
eLearning
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Want help...
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matching the right course to your needs? Please call 888 357 9001 or email
info@qmii.com.
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