No quick-fix regulatory solution for device software
This article was originally published in Clinica
Executive Summary
There is unlikely to be a quick formula to apply to software validation to ensure compliance with EU and FDA regulations because technology is moving at such a fast rate. That was the conclusion reached last month when the Medical Devices Quality Group (MDQG), a special interest group at the Institute of Quality Assurance, held a medical devices software validation workshop in London. So says Angie Glover, of the medical device consultancy, Quintiles Consulting.