FDA Consultants for:

FDA Quality System | FDA Regulatory Compliance | FDA Clinical Services
FDA Clinical Services to the Medical Device, Pharmaceutical, and Food Industries

About US

mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance, FDA Consulting, and clinical services to the healthcare industry.

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Our services are focused on assisting medical device, pharmaceutical and food companies across the globe achieve regulatory and
standard compliance.

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We provide tailored consulting services to the medical device, pharmaceutical and food industries.

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News & Info

mdi prides itself on keeping up-to-date, and in some cases ahead of the industry.
Our New and Information section is no different.

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FDA News & Information from mdiConsultants, FDA consulting specialists

Latest News

Why mdi?

We have worked with over 500 clients worldwide across the medical device, pharmaceutical and food industries. We have been in business since 1978. Our staff is comprised of former Quality Department Managers who understand your issues.
We have over 35 retainer accounts, of which 12 accounts have been with mdi for over 10 years Our full-time employees have been with mdi for an average of 13 years, which provides continuity and confidence to our clients; unlike other consulting firms where “associates” are brought on for 1-off projects
Fixed priced services – we provide you a pre-determined price for what we will deliver to you. If it takes longer than planned, mdi accepts the risk. You will know what the total project cost will be at the start of the project. Guaranteed 510(k) or ISO certification – we provide you a guarantee that you get 510(k) approval or first-time ISO certification, as long as you follow our recommendations and process


General inquiries, FDA crisis intervention and strategic planning assistance, e-mail sign-up

mdi Consultants by the numbers

Over 200 years of cumulative industry experience on staff

Helped over 500 companies achieve FDA compliance and/ or ISO certification

Successfully prepared and submitted over a 1800 510(k) applications

Earned a 100% success rate in first time ISO certification

Successfully assisted obtaining CE mark for over 1000 products

Trained over 12,000 healthcare employees worldwide

Our Clients