Does FDA Require IEC 62304??
Why this question arises? Medical device recalls, which are highly undesirable are not stopping are on rise. The devices which are coupled with software are amongst them and poses new challenges. Over a period with new development in IT, software use has become so much and inevitable, that one cannot say let us stop using them. The alternate way is to make it more control l ed and regulated. Software use has become so much that in some medical device it is playing very important role which is so detrimental that it also needs to control so regulator has made that software itself as medical device, so it automatically get governed by all applicable regulations. IEC 62304 standard came into existence due to above facts only. The standard is designed to provide lifecycle approach to govern software. Life cycle approach with activities and tasks to govern safe software design and maintenance of the same. Each life cycle process is further divided into many sets of activities an...