Medtech complaint handling: Is there something to complain about?

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Only

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

5 mistakes that can turn your product registration into a money drain

Medical device registration may seem straightforward but is actually prone to potentially costly mistakes.  Medical device organizations are required to register medical devices with notified bodies in all countries where they sell those products. This process is fairly well understood and expected. However, there are pitfalls in the practice of compiling the dossiers to register,