mdi Consultants – Medical Device, Pharmaceuticals & Food Industries Consultants
mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations.
ABOUT MDI CONSULTANTS’ APPROACH
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)
ABOUT MDI CONSULTANTS’ STAFF
The company’s principals, Alan P. Schwartz and Dr. Anand Akerkar have carefully selected a group of consultants who have accumulated extensive industry experience dealing with U.S., European and Canadian compliance concerns. Our staff has deep knowledge in all FDA compliance issues (e.g. device and pharmaceutical submissions, quality system compliance, clinical trial management, Food Safety, HACCP) as well as European compliance issues (e.g. ISO 9000, ISO 13485, ISO 22000, CE Mark, MDD, IVDD, AIMDD). The staff includes a number of former FDA officials, ISO lead assessors and industry quality managers.
ABOUT MDI CONSULTANTS’ LOCATIONS
We are headquartered in Great Neck, New York (just outside of New York City) and have 11 representative locations worldwide. Our US and other international locations include:
Los Angeles, CA