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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.


FDA Update:

LIFE after the EUA

By Alan Schwartz
YES, there will be a day when the US EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality and the FDA regains control of the medical approval process with the “a REAL” device review in place.
In my almost 5 decades of FDA experience, this is the first time I have ever seen an EUA put into practice — but, in real terms, what is an “EUA,” and why it is used so infrequently?


Industry Update:

MDR postponement – handle with care!

The proposal for a one -year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step in the process will be a sign-off by the European Council. This is rather a formality – as such, experts agree that economic operators may adapt their transition plans accordingly.


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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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


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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

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