mdi Consultants, Inc., has been providing regulatory affairs and quality systems consulting service since 1978. We have assisted with over 1000 510(k)s applications, set up and implemented over 400 Quality Systems worldwide and performed over 600 mock audits for FDA QSR/cGMP compliance. We provide FDA strategic planning and FDA troubleshooting, well crafted responses to FDA 483s and W/Ls, set up and run clinical trials. mdi has extensive experience in setting up quality systems and obtaining certification for ISO13485, preparing Technical Files for the CE mark for both the EU and Canada. Our staff consists of both former US FDA officials and industry experts. We have several Internationally Certified ISO 13485 Lead Assessors. We perform in-house training programs on all aspects of FDA and ISO and assist our clients in Design Control, FMEAs and contractor responsibilities. Our Clients include both the start up operation to the Fortune 100 companies. For more information on mdi please visit mdi’s website at: www.mdiconsultants.com