ISO 14971 is one of the ISO standards that define the international requirements for medical device manufacturers by managing risk associated with the use of medical [...] Read More
Most life-sciences firms would agree that the best way to prepare for FDA Warning Letters is to take measures that prevent them from ever coming. Unfortunately, regulatory compliance is a complex beast, and it’s rarely possible to do everything perfectly.
Comprehensive compliance [...] Read More
How do you know your life sciences firm is maintaining compliance? While FDA audits and warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they’ll continue to do so [...] Read More
Although it was originally developed for high-risk military assessments, Failure Mode and Effects Analysis (FMEA) methodology has become essential for medical device manufacturers. Firms that want to market products intended for human use must provide some assurance that these [...] Read More
Your firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.
While it would be nice to prevent such issues [...] Read More