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mdi News:

EUA approval on an IgM/IgG Rapid Test

On September 23, 2020, mdi Consultants successfully obtained EUA authorization for our client Jiangsu Well Biotech Co., Ltd.’s “Orawell IgM/IgG Rapid Test”. This is only the 16th rapid antibody test authorized by the FDA to identify the presence of both IgG and IgM antibodies since the EUA period began in March, 2020. Throughout the FDA review process, the FDA continued to tighten the requirements for these tests, especially for tests being manufactured outside of the country (ie. China).


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.


mdi Consultants Support During the Coronavirus Pandemic

Dear Clients and Partners,

As the world continues to navigate through the Coronavirus pandemic, we wanted to update all our current clients, partners and those companies in need of future assistance on what mdi Consultants is doing to provide the highest level of regulatory consulting services and most importantly, uninterrupted support.

mdi has been in business since 1978 and collectively, we accumulated 100’s of years of unmatched expertise in all areas of FDA and other international regulatory bodies compliance. We are committed to safeguarding the health and safety of our employees so they can continue to be relied on as a trusted asset to your organization.

We are following the CDC guidelines as well as recommendations of local New York State and county officials with regards to hygiene practices, minimizing close contact and group assembly requirements. Every one of our employees has complete capabilities to work remotely with full access to client files and project materials. Due to the nature of our business, we have been remotely interacting with many of our international and local client companies for years, as our IT Department based our operational system on a fully digital platform.

Accordingly, we want to assure you that all ongoing and future projects will continue to be managed smoothly and expertly by our qualified consultants. If on-site support is required, we will look to provide it by using local, in country consultants in a safe and situation appropriate manner. At the same time, if we determine that on-site assignments can be handled remotely, we will work with our clients on the plan to best accomplish this.

Also, please note the US FDA and other international health agencies are considered essential government services and will continue to remain operational during this time. As many other agencies with contingency plans in place, FDA reviewers are able to work from home, remotely, to process various submissions. There may be occasional delays and extended timelines but the review process at the government agencies will go on. As for FDA on-site inspections, the FDA has presently put a hold on foreign inspections and we are seeing that inspections in the USA are being put on a hold as well. This seems to be on a case by case basis. We will keep you updated on any changes that we see as they occur.

As always, mdi Consultants are open to discuss any specific questions or concerns you may have with regards to your particular situation. Please reach out at info@mdiconsultants.com and we will be happy to assist.

Stay safe, remain calm and we will get through this together.

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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mdi assists Taiwan company pass FDA inspection




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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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