.... Understand the essentials of Medical Device Validation.
Medical Device Design, Manufacture, Processing, Release to Customers, Product Use
US FDA, EU MDD requirements
Statistical and Quality Improvement Methodologies
Validation of Medical Devices
For those individuals involved in the development and manufacture of medical devices,
there is a need to implement continuous improvement processes.
Remaining up to date with regulatory requirements, and ensuring you have a comprehensive
knowledge of not just regulatory demands but also an understanding of continuous
improvement approaches can be costly and time consuming.
Basic Introduction to Validation >>>
Introduction to the PQ, IQ, OQ, etc., stages in Medical Device Validation >>>
Regulatory requirements of bodies such as the US FDA, or the European Medical Devices
must be clearly understood where either you or your peers are involved in the product
life cycle of a medical device.