What Clients say about mdiConsultants, Inc.
Below are samples from several of our clients’ testimonials with whom mdiConsultants, Inc., have been working . You will find that our clients have been extremely satisfied by our expertise, knowledge and professionalism. They have also derived significant value from working with us. We are confident that you will as well.
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.
Banyan USA, Inc.
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.
Merits Health Products Ltd.
Taichung City, Taiwan
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.
Bill Birdsall, Esq.
Chief Compliance Officer
West Hollywood, CA 90069
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
Premier Heart, LLC
Port Washington, NY 11050
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
Fabrication Enterprises Inc.
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
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
VP, Design and Development
Regulatory Affairs Specialist
Vamed Medical Instrument Co. Ltd.
CEO, VP of Dental Research