Non-compliance issues show that users find dealing with computer systems challenging. Quality management of computer systems (hardware and software) is a central part of the overall quality management ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...