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| About site: Healthcare/Products and Services/Medical Equipment - MDI Consultants, Inc. |
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| About site: http://www.mdiconsultants.com/ |
Title: Healthcare/Products and Services/Medical Equipment - MDI Consultants, Inc. A FDA, IVDD, CE mark, HACCP, ISO9000 and GMP compliance consulting company for the medical device industry. |
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FDA Consultants | Medical device consultants & pharmaceutical and Food industry consultants | 510(k)Submissions
a medical device, 510(k)Submissions, U.S. Agent, CE mark, ISO 9000, FDA, Pharmaceutical and quality assurance, regulatory consulting company and Authorized Agent,
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FDA Quality Systems | FDA
Regulatory Compliance
FDA Clinical Services to the
Medical Device,
Pharmaceutical and Food industries.
mdi Consultants, Inc.
A Medical Device Consulting, U.S. Agent, CE
mark, ISO, Pharmaceutical and Quality Assurance, Regulatory
Consulting company and Authorized Agent
510(k) submission
assistance
FDA
Trouble Shooting
483 & Warning Letter Responses
Quality System Compliance

On Demand Training Programs for
QSR compliance
CAPA
Design Control
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mdi Consultants Inc. is the leading
provider of quality assurance, regulatory compliance and clinical services
to the Medical Device, Pharmaceutical and Food industries. Since 1978 we
have been providing clients the following high-quality and high-value
consulting services:
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& WEB SITE
DEVELOPMENT
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FOR
MEDICAL DEVICE
COMPANIES
FDA compliance – regulatory strategy
development, clinical trial development/ management, cGMP compliance,
on-site audits, validation (process, software and sterilization) and
510(k)/PMA/ANDA/NDA submission services
ISO compliance – ISO 9000:2000, ISO 14000,
ISO 13485:1997 (EN46001), EN540 and Quality Systems
Crisis Intervention – FDA audit response
(483), warning letters, and product recalls
European compliance – CE mark, Medical
Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and
Active Implantable Medical Device Directive (AIMDD)
Other industry-related services – HACCP,
In-Vitro Diagnostic Research and Development, U.S. Agent (for non-U.S.
companies), sales force performance improvement, and marketing assistance
mdi leverages a proven and tested
methodology with seasoned and experienced consultants. With over 200
years of cumulative industry experience on staff, we have delivered the
following results:
Helped over 500 companies achieve FDA or
ISO compliance
Submitted over 400 510(k)s
Earned a 100% success rate in first time
ISO certification
Implemented over 150 complete quality
systems
Successfully assisted over 200 products
(Type IIa or above) for CE Mark
mdi is the first in the industry to offer a
unique fixed price business model and an innovative performance guarantee.
Please contact us for more information on our services and our performance
guarantee.
Please visit the industry section of the
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A | FDA, | IVDD, | CE | mark, | HACCP, | ISO9000 | and | GMP | compliance | consulting | company | for | the | medical | device | industry. |
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http://www.mdiconsultants.com/
MDI Consultants, Inc. 2008 October
dvd rental
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A FDA, IVDD, CE mark, HACCP, ISO9000 and GMP compliance consulting company for the medical device industry.
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