| 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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mdi Consultants, Inc.A Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent
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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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Global Business Development Center
Announced mdi Consultants Inc. to anchor turnkey solution for companies building U.S. presence Read Press Release |
Supply Chain Oversight is the FDA's Next Area of Concern: What Does that Mean for You? Read The Complete Article |
Alan Schwartz. Vice President, mdiConsultants, Inc., spoke at
the
seminar for the Shandong, China FDA Delegation...<<Click
for Details>>
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FOR THE LATEST
mdi Consultants, Inc. signs agreement with
CCUS in Beijing.
VIDEO TESTIMONIALS
"THE COMPETENCE AND PROFESSIONALISM OF YOUR COMPANY IS UNSURPASSED
IN THE INDUSTRY" |
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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
Health Canada compliance – medical device licensing, establishment licensing, private label licensing, label review, quality system ISO 13485 certification by CMDCAS recognized registrars
European compliance – CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)
Electronic drug listing and registration, FDA drug listing and registration, electronic listing and registration”
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 website for industry specific offerings. Our monthly newsletter, the Insight Report, and FDA updates are always available on-line.
Please visit our client testimonials section to see both our video testimonials as well as letters we have received from our clients on the value mdi provides.
