mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.
We utilize the following three part approach to providing high quality services to our clients:
Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients
Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment
Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)