Mike Zeevi is a senior consultant for software validation and software quality assurance for the life science industry (medical devices, drug and bio-tech companies). Mike is also a leading authority on the CE’s and the FDA’s requirements for software validation including Annex 11 and 21 CFR Part 11. Mike has mentored numerous companies in validating their operational and support software. Mike has also helped many companies in setting up a software quality system that complies with FDA and CE regulations and is practical (and is really used).