More Client Testimonials
Below is a brief sample of our clients’ testimonials on
working with mdi. You will find that our clients have been extremely
satisfied by our expertise, knowledge and professionalism. They have also
derived significant value from working with us. We are confident that you
will as well. We also have a partial list of our clients. To view this list
please click here.
Letters:
Testimonials:
Dear Alan, Yes, the FDA QSR Inspection results were
excellent.
I contribute that to the commitment and hard work of a few
individuals at CAD-S.
But, there is no way we would have made without Mohan’s knowledge,
guidance and diligence.
We actually had a relatively good QS in place, but due to a number of
issues, it had been neglected for the past 12 months.
Mohan’s systematic approach, from day 1, slowly but surely
got everything in order. With a skeleton crew, it was frustrating, at
times. But Mohan was patient and methodical and worked with us to the
very end to ensure that we were in compliance.
I would work with Mohan, any day and please feel free
to use your work and achievements at CAD Sciences as a reference.
Thanks,
Jan Mintorovitch, Ph.D.
Chief Scientific Officer
CAD Sciences
White Plains, NY
“Your regulatory strategies for a 510(k) application
versus an IDE/PMA saved the company from unwanted time delays and
crippling financial setbacks. We are fortunate to have an organization
like yours to support our efforts…Please feel free to forward any
potential new clients to my attention for professional or personal
references.”
John Giungo
VP,
Design and Development
Photogenesis
“[mdi] working with the FDA reviewers was able to save
us $1,000’s in retesting dollars and even further delays. I would have no
hesitation to recommend mdi to others in my field.”
Drew Queen
Regulatory Affairs Specialist
Fukuda Denshi
“I am happy to inform you that your hard
work and knowledge of the FDA rules and regulations have been…successful
in helping Rozinn Electronics avoid a warning letter…This means so much to
the reputation of our organization…In the future, you can be sure that
anyone who needs help in regulatory affairs will be referred to MDI by
Rozinn Electronics. The competence and professionalism of your company is
unsurpassed in the industry.”
Mask Rosoff
President
Rozinn Electronics
“I wouldn’t think of experiencing an FDA audit without
MDI’s assistance. I would highly recommend any company especially a
foreign company to use MDI for dealing with the FDA.”
XiChang Li
CEO
Vamed Medical Instrument Co. Ltd.
“I would like to…express my appreciation along with the
entire EDS staff, for your assistance and guidance in our effort to obtain
ISO and CE Mark certification. MDI’s commitment in helping us achieve our
goal for certification two years before schedule was done in a
professional and timely manner. Thank you!”
Brett I. Cohen, Ph.D.
CEO,
VP of Dental Research
EDS
“I believe that we could not have gotten better results
if we had not had [mdi] there with us. Your high degree of skill and
professionalism is much appreciated.”
Ken Shirahata
General Manager,
International Sales/Marketing
Pentax
“Your patience and ability to work with the FDA staff
are a tremendous plus for companies like ours. Your understanding of the
workings of the Agency and the relationships that you have with some of
its people help to provide additional insight into government bureaucracy
that never seems to make any sense.”
David Geraghty
Regulatory Affairs
Manager
Fukuda Denshi
“I deeply appreciate the outstanding service that you
and MDI have provided our Company over the last 10 years. Your thorough
knowledge of regulatory laws and keen negotiating skills have literally
saved our company from being put out of business by the FDA. We have also
profited by following the many practical suggestions you have offered on
ways to operate our Company more efficiently. I am confident that your
help will be instrumental in our continued growth and success.”
Chip Garber
President
J&J Engineering
“24 days for clearance of 3
products, not too bad!! This is a new record in Microlife. Thank you for
your outstanding work.”
Gerhard Frick
Director of Regulatory Affairs
Microlife
“When colleagues want help with Regulatory issues, I tell them that I
had success because I had a great consulting group fighting for me and
that they should give mdi a call!”
Lauren Ziegler
Senior Manager,
Technical Services
Respironics Healthscan, Inc.
“The whole mdi organization put in an extra effort in
the preparation of our submittal. It was a very thorough and complete
package, which I believe was reflected in the timely response we received
from the FDA. I look forward to a continued relationship with MDI and many
more successful projects.”
Mark C. Schmidt
Director, Vascular Access
Products
Aeroquip, a Trinova Company
“Your professional handling of the
FDA official and overseeing how our management responded to FDA’s
inquiries was an integral part in the process of the inspection. Your
presence made the inspection…smoother, assured Foshan in passing the
inspection and resulted in continuing compliance with the US FDA GMP and
regulations preventing any interruption in our being able to ship products
to the US.”
Bai Xianzhong
Director
Guangong Huatong Medical Equipment Development
“We are writing this letter to thank mdi…for the hard
work and dedication that he gave our Company in helping us obtain CE mark
certification. Numerous times during the inspection the notified body
auditor exclaimed at the wonderful job Medipoint had done, over and above
the requirements. We know that this is due to [mdi]”
Peter Gollobin
President
MEDIpoint, Inc.
“…Lumex Medical Products successfully passed an
ISO9001 certification audit performed by the German registration body
Med/Cert. We would not have been able to achieve such an important
objective without the help of [mdi]…we were able to put in place a quality
system that is both harmonized and complies with not only ISO9001, but
also EN46001 and FDA cGMPs.”
Clyde Granger
Manager of Quality
Lumex, a
Graham-Field Company
“We have landed a big order just right after the FDA
approval, all thanks to you. I really want to thank you, you have done a
great job for us, even our US customer praised your work when they made
inquiries to the FDA in regarding our 510(K) status.”
James Chen
Oriental System Technology
“I am delighted to hear the good news of our product
getting the necessary FDA clearance…getting 510K clearance from the FDA
would not have been possible without the diligence and long hours of hard
work by [mdi]…this allowed us to forge ahead with our plans to implement
product development plans.”
Kostaki G. Bis, M.D.
President
Magnetic
Moments, LLC
“I would like to offer a very special thanks for providing
the services..for our quest in achieving the CE mark…He provided a very
feasible approach in meeting all the requirements of cGMP, ISO, EN and the
European directive. His strategy was very practical in developing the
system to meet the needs of the organization and minimizing the amount of
maintenance for the quality assurance system…We look forward to working
with your company and building a solid relationship for years to come.”
Lakshman Agadi
President
MedGyn Products, Inc.
“When I asked you a year
ago, to consult with Colla-Tec for an ETO sterilization validation
program, it seemed like a routine request….your input with our company has
been very valuable. Colla-Tec’s most recent FDA inspection is evidence
that what you taught our employee’s really did register.”
Judith O’Grady, RN, MSN
VP,
Regulatory Affairs
Colla-Tec, Inc.
“I would like to thank mdi for helping our firm in the
last few years in our efforts to become fully compliant to FDA
requirements…this inspection took place over a three-day period and
involved an intense review of all our quality system. Our success was
defined at closure…this is a “first” for MedX96, as previous audits have
not been so successful.”
Susan Bowen
Quality Coordinator
MedX96
“I would like to take this opportunity to recognize mdi
Consultants for the outstanding work that was performed for Essex
Cryogenics before and during our recent certifications. Essex Cryogenics
was awarded on 12/20/2001 ISO-9001 1994 as well as EN 46001. The support
that mdi rendered made it possible for us to perform well during the audit
and receive our certification the first time..”
Russell Zavadil
Quality Assurance
Manager Essex Cryogenics
“I would like to take this opportunity to personnally
thank you for your efforts towards obtaining ISO compliance and
certification recommmendation for Covance Central Diagnostics…mdi
Consultants, Inc. has delivered on every commitment they have made. You
and your firm have certainly provided client satisfaction to this client.”
Cherie Neal Director
Quality Assurance
Covance Central Diagnostics, Inc.
“I want to send this letter to thank you for all your
help with getting Rex Medical ISO9001 approved…we consider you a VALUED
MEMBER OF OUR TEAM.”
Peter Hinchliffe
VP, R&D
Rex Medical
“At this instance we very highly appreciate the efforts
put in by mdi Consultants. In preparation of the manuals, the GMP
procedures, the meticulous detail which were gone into with our team to
bring to success the level of competence in a short span of time so as to
enable us to present ourselves for the rigorous audits enforced by FDA
authorities.”
S.V. Karkanis
President Director
P.T. Saptindo Surgica
“This letter is to express our appreciation for the
excellent work you and your organization have done on our behalf. Four
areas particularly come to mind: guidance in initial project management,
establishment of GMP systems and training, the performance of clinical
trials on our HIV diagnostic test, and interfacing on our behalf with U.S.
and Canadian regulatory agencies. All of these activities have resulted in
great benefit to our company.”
Charles B. Beal, M.D.
Vice President, R&D
Empyrean Diagnostics, Inc.
“I would like…to personally thank you for your
assistance and guidance in the acquisition of the 510K approval for our
computerized medical scanner…we appreciate your availability and wisdom,
without which the process would have been much more difficult."
Martin E. Doyle
Chairman and CEO
Perception Ultrasound
“It give me great pleasure placing on record that your
presence before and during the US FDA Audit was a great deal of help.”
Dr. S.B. Singh Senior
Manager,
QA
Suretex Limited
”I am very glad to learn that the FDA audit had been
finished without serious problems under the strong support and a mock FDA
audit from mdi prior to the FDA investigator’s visit.”
Masayuki Shinoda
President
Colin Corporation
“We appreciate the efforts you are continuing to make to
bring our company into ISO 9001 Certification and Compliance.”
R. Adam
Crane
President
American Biotec Corporation
“I am pleased that our hard work and your continued
advice and support since we received our “Warning Letter”, has brought us
to this happy ending.”
Peter Galambos
President
G-Five Corporation
The testimonials above are excerpts
from letters that we have received from our clients. You can download
Adobe Acrobat file of these letters by clicking here. Please note that
this can take some time to download.
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