Setting-up a successful software vendor evaluation/qualification process for `off-the-shelve´ commercial software used in medical devices

With the ever increasing amount of software being used in medical devices today, it makes sense to take advantage of existing commercial off-the-shelf (COTS) software where feasible as opposed to developing a similar software package in-house. The advantages of this strategy are the cost savings of not implementing a full scale software development project as well as a reduction in the time to bring a product to the market place. Some examples of these software packages are operating systems, display managers, peripheral interfaces or communications protocols. However, you must a processes for evaluating software packages for their ability to meet your needs and a process for qualifying them to meet the strict regulatory guidelines for use in medical devices