Testimonials From Clients

To Whom It May Concern:

How does a small, growing business navigate the FDA medical device registration process?

Short answer – they really don’t, even after hours & hours of research!

mdi Consultants are not only super professional, expedient and amazing at what they do but they are also caring, real humans who made the process of registering our company and medical device with the FDA effortless for us.

Finding mdi Consultants is a great example of why we always look for people to join our Team that can do something we do even better – the mdi team is awesome at what they do and they understand (and patiently explain) the FDA system and processes.

Thank you, mdi Consultants 🙂

Holli Markwald
CEO
Prairie Wear Ltd.
Calgary, Canada

Dear Alan,

We want to thank mdi for your assistance with the most recent FDA inspection of our facilities in Taiwan.

Your guidance and composed demeanor throughout the inspection demonstrated your extensive experience and expertise in navigating FDA inspections and working with FDA investigators.

The inspection results were outstanding, and we cannot imagine going through future FDA inspections without the support of mdi. We strongly recommend mdi to any organization seeking assistance with the FDA.

Once again, we express our gratitude for your exceptional expertise and experience in ensuring the success of the inspection.

Best regards,

Jonathan Cheng
President
Merits Health Products Co., Ltd.
Taichung City, Taiwan

Dear Alan,

Thank you for the great news! We are very happy and excited PlasmaShield  has been 510(k) cleared! This obviously means a lot to Plasmatica.

We wanted to send you our deep appreciation for all the hard work you and your team have put in to help us achieve this important milestone! Special thanks to Susan and Vaibhav who have guided us through the process in such a dedicated and professional manner, leading us through every step of the way with their genuine care and commitment to us and the project.

We look forward to working together on our future projects!

Thanks

Adam Sagiv
Founder & CEO
Plasmatica LTD
Ra’anana Israel

Dear Alan,

I want to thank you for the excellent work, directed by you and you team, regarding for regulatory services for our Banyan USA surgical face masks. We are delighted to have received our 510(k) clearance especially during these challenging times.

We are also confident that the quality system, process validation and ongoing regulatory consulting assistance by mdi, will aid us in making sure we meet the FDA standards necessary for future compliance of our products and systems going forward.

As originally discussed on the first day we met, this entire process was new to us and your professionalism and guidance was, and continues to be, well worth the investment.

Sincerely,
Bill Reitzig
COO
Banyan USA, Inc.
Farmingdale, NY

Dear Alan,
I am writing this letter to thank you for the professional support from mdi Consultants Inc. through the mock audit and the FDA inspection.

During the mock audit, all the key points of the QSR were emphasized, thus, we have the document ready and got prepared for the formal FDA inspection. With your professional guide and support, we finally successfully pass the FDA QSR inspection without receiving the 483.

It has been almost 8 years since we had mdi Consultants to come to our company and help us to improve our quality system for complying with FDA QSR. We would highly recommend any company who has problem to comply with FDA QSR should certainly consult with mdi. Again, thank you so much for all the help! Hope everyone at mdi enjoy the holiday seasons.

Happy holidays!
Best regards,
Jonathan Cheng
Vice President
Merits Health Products Ltd.
Taichung City, Taiwan

Hi Alan,

I would like to express gratitude on behalf of all of us at Pearl for the outstanding contributions made by Dan Aisen to the development of our company Quality Management System during his visit this week.

Dan’s passion for, and comprehensive understanding of, every single aspect of Quality Assurance was remarkable and contagious. His suggestions and contributions were extremely helpful; but, most significantly, he has instilled all of us here with an understanding of the real value of quality management and a commitment to creating the best system we can.

We are grateful for his effort and contributions and look forward to his further input as our system comes to life.

Thank you

Bill Birdsall, Esq.
Chief Compliance Officer
Pearl
West Hollywood, CA 90069

Hello to whom it may concern,

Our experiences working with Alan Schwartz and particularly Natalya Valerio of MDI have been nothing but the best experiences we’ve had dealing with regulatory consultants.

I can confidently recommend their high quality, professional work. If you’re working with them, I can say for sure that you are in great safe hands.

Joseph T. Shen, MD
Founder/Managing Member
Premier Heart, LLC
Port Washington, NY 11050

Dear Alan,

We want to express our appreciation for MDI’s guidance and assistance in helping us achieve our MDSAP (Medical Device Single Audit Program) certification. At this time, the MDSAP process is very new to both the companies wishing to obtain certification and the auditors. Success is only possible with in-depth understanding of all MDSAP requirements and their complete implementation.

The MDI Consultant team worked closely with our staff throughout the entire process providing stable and consistent support. Though there were several unexpected obstacles along the way, you continued to work and support the FEI staff to achieve its goal.

MDI’s professional and timely commitment to helping us achieve the MDSAP certification goal is exemplary. We hope to continue to work with MDI to support the compliant operations of our quality system as well as for other future projects.Elliot Goldbesrg
President
Fabrication Enterprises Inc.

Dear mdi Consultants Team,
I would like to thank you for your excellent efforts and commitment in assisting us to obtain 510(k) clearance. I am impressed with your dedicated ans professional FDA submission team that has helped us avoid unfavorable deficiencies that may have led to additional cost and time delay. Thank you once again and looking froward to working with you future projects.Henry Kao
Regulatory Affairs Specialist
Carilex Medical, Inc

Dear Alan,
I want to thank Suzan, you and the whole MDI Consultants team.
This project has not been our first with you, and it was a pleasure to find out that you still maintain the professionalism and abilities that defined you in the past and even improved it.
BRH Medical is relieved to be post the stress, post the uncertainty and with the approval ready to start working properly.
Thank you so very much for the thorough work and for the time, the hours, the round-the-clock efforts and for making this happen.
We feel that your professionalism in so many fields: electronic regulation, software regulation, EMC, safety, Medical regulation, Ultrasound and electric fields regulation and the vast knowledge in so many sub clauses was the key for the success of this project.
Thank you once again for this ending project and looking forward to working with you on future projects.
Yours Ilan, on behalf of the entire BRH Medical teamIlan Feferberg
CTO
BRH MEDICAL

Your regulatory strategies for a 510(k) application versus an IDE/PMA saved the company from unwanted time delays and crippling financial setbacks. We are fortunate to have an organization like yours to support our efforts…Please feel free to forward any potential new clients to my attention for professional or personal references.John Giungo
VP, Design and Development
Photogenesis

(mdi) working with the FDA reviewers was able to save us $1,000’s in retesting dollars and even further delays. I would have no hesitation to recommend mdi to others in my field.Drew Queen
Regulatory Affairs Specialist
Fukuda Denshi

I am happy to inform you that your hard work and knowledge of the FDA rules and regulations have been…successful in helping Rozinn Electronics avoid a warning letter…This means so much to the reputation of our organization…In the future, you can be sure that anyone who needs help in regulatory affairs will be referred to MDI by Rozinn Electronics. The competence and professionalism of your company is unsurpassed in the industry.Mask Rosoff
President
Rozinn Electronics

I wouldn’t think of experiencing an FDA audit without MDI’s assistance. I would highly recommend any company especially a foreign company to use MDI for dealing with the FDA.XiChang Li
CEO
Vamed Medical Instrument Co. Ltd.

I would like to…express my appreciation along with the entire EDS staff, for your assistance and guidance in our effort to obtain ISO and CE Mark certification. MDI’s commitment in helping us achieve our goal for certification two years before schedule was done in a professional and timely manner. Thank you!Brett I. Cohen, Ph.D.
CEO, VP of Dental Research
EDS