Malfunction reports. The obligations of medical device manufacturers and distributors
Regulatory agencies around the globe have very concrete laws which pertain to handling malfunctions of medical devices.
The Israeli Ministry of Health published a law in 2012 which stipulates that the organization which registered the device for distribution is obliged to follow and control its normal and failure free operation. Further, it is obliged to report any failure which was brought to its attention, whether it happened in Israel or abroad.
To be able to handle reported failures the organization has to have a structured and professional system in place. To establish such a system requires expertise and experience. Whether it is done by an in-house or an outsourced team, make sure it is done by professionals. In those matters there is no room for errors, bad handling of malfunction reports can expose the organization to excessive legal, economic and regulatory sanctions.
Medicalix has both, expertise and many years of experience working with the largest multi-national companies on pharmacovigilance and quality issues.
“Image courtesy of iosphere/ FreeDigitalPhotos.net”.