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.
Let us provide you with a convenient approach to enhancing your understanding of
medical device regulatory requirements.
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If you are involved in the design, manufacture, processing, of medical devices you
will need a comprehensive understanding of the various regulations that must be applied.
You will need to be able to demonstrate to regulators the consistent application
of good manufacturing practices, effective root cause analysis where appropriate,
efficient feedback processes, staff competency evaluation, etc.
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.