Events tagged "FDA Quality System":

Online Training

This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime. Read more »

Online Event

Why Should You Attend:

Many medical devices are controlled by software that governs key aspects of the user interface, and performs key safety functions. Users often do not realize the extent to which software determines many of the key functional and performance characteristics of the system until something goes wrong. Unfortunately, in some cases, the software does “go wrong” and compromises performance reliability and patient safety. Because software is inevitably complex, abstract, and intangible, design errors can be difficult to detect. The occurrence of a software error should be a highly unusual event. Read more »