The FDA has issued an EUA (Emergency Use Authorization) for Surgical Masks, N95 Masks, Ventilators and COVID-19 diagnostic kits. mdi is assisting companies with the prep and submission of the EUA to the FDA.
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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 510(k).
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We have extensive experience in helping medical device companies across the world successfully enter and obtain market approval in the United States, Europe and Canada
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We have extensive experience in helping pharmaceutical/CRO companies across the world successfully enter and maintain
market approval in the United States and Europe.
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We have extensive experience in helping food companies across the world successfully enter and maintain market approval in the United States.
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.
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?
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.
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