Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.
A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging, and even thought control of computers. It is increasingly being used for e-records and e-signatures.
The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues.