FDA Quality Systems | FDA Regulatory Compliance
FDA Clinical Services to the Medical Device,
Pharmaceutical and Food industries.

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:

	FOR THE LATEST INDUSTRY NEWS CLICK HERE mdi Consultants, Inc. signs agreement with CCUS in Beijing.  Cick here for story VIDEO TESTIMONIALS FROM OUR CLIENTS CLICK HERE "THE COMPETENCE AND PROFESSIONALISM OF YOUR COMPANY IS UNSURPASSED IN THE INDUSTRY" MARK ROSOFF, PRESIDENT PRESIDENT ROZINN ELECTRONICS FDA UPDATES
	INTERNET MARKETING & WEB SITE DEVELOPMENT SERVICES 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 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.

SEARCH |   Home  | Help | Contact