Medical Device Post Market Surveillance
Analysis and review of post-market surveillance data is part of the risk management process and should be performed by companies on a routine basis. Ideally, these reviews are performed during formal management reviews held as mandated by QSR and ISO 13485.
Post-market surveillance data are collected following key procedures including: customer complaints and other feedback, control of non-conforming products, corrective and preventive actions, servicing, customer surveys, surveillance of competitive products, etc.
Smestad & Associates can help your company set-up effective procedures using best practices describing who reports and reviews these data, how the collected data are reviewed, analyzed and trended, including the frequency in which this is performed.