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About mdi
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.
OUR 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 to U.S. Congressmen)
OUR 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) as well as European compliance issues (e.g. ISO 9000,
ISO 13485, ISO 14000, CE Mark, MDD, IVDD, AIMDD). The staff includes a
number of former FDA officials, ISO lead assessors and industry quality
managers.
OUR 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: U.S.
Atlanta, Georgia
Boston, Massachusetts
Orange County, California
Phoenix, Arizona International
Guadalajara, Mexico
Hamburg, Germany
Seoul, Korea
Shenzhen, China
Sialkot, Pakistan
Tokyo, Japan |
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