mdi Consultants

mdi Consultants is a leading regulatory compliance and quality assurance consulting firm with over 45 years of experience serving the medical device, pharmaceutical, and food industries. The company specializes in FDA and international regulatory strategy, quality system implementation, clinical trial management support, 510(k)/PMA/ANDA/NDA submissions, ISO certification assistance, CE marking for EU market access, audit response services (including FDA Form 483s and warning letters), and ongoing compliance training. They have helped over 500 companies achieve FDA or ISO compliance and submitted more than 1800 successful 510(k) applications with a strong track record of first-time ISO certification success.