Post Market Surveillance, as described in the new Medical Device Regulation, is a new concept. A manufacturer shall know at all times how his product performs in the field.
Is reporting required when you implement corrective actions within your company, if the information is derived from PMS data? Learn how the PMS data is utilized to improve your product. Plus, be aware that even your NB is being monitored and scrutinized with your data! You will also be made aware of the implications of your quality system.
presented by Ludger Möller