Creation and Maintenance of Lean Quality Management Systems for Class I, 510(k) exempt Medical Device
Tackling FDA Quality System (QS) regulations can be confusing, especially for Class I 510(k) exempt medical devices. We know the challenges firsthand and have designed this course to make the process clearer and more engaging.
In this course, we'll guide you through the essential elements of a Quality Management System (QMS) as outlined in 21 CFR 820 and explain the differences in QMS requirements for different types of class I, 510(k) exempt devices. You’ll learn about management responsibilities, risk management, design and document controls, production and process controls, CAPA, complaint handling, training, and more with a focus on practical implementation.
This course isn’t just about compliance; it’s about integrating quality practices into your company’s culture. Through lively discussions and real-life case studies, we’ll explore how to weave these principles into your daily operations.
Led by deeply experienced professionals from the medical device industry, our sessions are designed to be dynamic and insightful, making the learning process engaging and relevant. We aim to guide you in building a robust and agile quality system that not only meets regulatory requirements but also drives continuous improvement and allows for innovation.
Join us to gain the knowledge and tools needed to excel in FDA QS regulations, and transform your approach to quality management.
