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

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FDA News & Information from mdiConsultants, FDA consulting specialists

Recent publication:

Medical Device magazine

Dealing with the FDA

With the FDA beginning to inspect medical companies once again following the slow down due to Covid 19, it is important - especially for new companies - to know what to do when faced with the representative. Alan Schwartz, executive vice-president of mdi Consultants, offers expert advice on how to deal with the FDA and their issuance of an affidavit.

mdi News:

Crown mutual Group

mdiConsultants and Crown Mutual Medical Group Announce Alliance

CMG, a Canadian based medical supply manufacturer, supply chain management services provider, and fully integrated services provider, supplying certification and consulting services to global healthcare enterprises.
CMG is proud to partner with mdi Consultants for global regulatory services for FDA, Health Canada, and other jurisdictions; and, Kinectrics.com for ASTM product certifications CGM Corporate office is headquartered in Vancouver, British Columbia. With manufacturing facilities in Delta, British Columbia, CMG affiliate global office locations include Toronto, Ontario, Las Vegas, Nevada, U.S.A. and Shenzhen, China.

mdi News:

mdi Consultants are among 10 Most Trusted Healthcare Consulting Companies 2022

MDI Consultants: A Leading Healthcare Consulting Services Provider

Every year, healthcare and other wellness companies across the world come up with innovative products, such as medical devices, drugs, medicines, patient operating machines, etc. They all must go through the regulatory compliance of the Food and Drug Administration (FDA) to get their approvals. To get the go-ahead from the FDA, various processes need to be followed.


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

Success story

mdi assists Taiwan company pass FDA inspection





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