Hello all CE certified friends...
With the 2012 started, many of you will be up with your MDD assessment plans with your NB for the continued CE certification.
Here find the process for sampling of Technical Files to be done by your NB in accordance with the European Council Directive on Medical Devices.
The Technical File for every device is and should be a living document that is continually updated with information from various sources, such as new or amended harmonized standards, post market surveillance from risk management, customer complaints, design changes, clinical experience and new clinical evidence and the general acknowledged state-of-the-art.
Happy CE.
With the 2012 started, many of you will be up with your MDD assessment plans with your NB for the continued CE certification.
Here find the process for sampling of Technical Files to be done by your NB in accordance with the European Council Directive on Medical Devices.
The Technical File for every device is and should be a living document that is continually updated with information from various sources, such as new or amended harmonized standards, post market surveillance from risk management, customer complaints, design changes, clinical experience and new clinical evidence and the general acknowledged state-of-the-art.
Happy CE.
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