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Medical Device Pros, LLC

Medical Device Pros, LLCMedical Device Pros, LLCMedical Device Pros, LLC

Medical Device Pros, LLC

Medical Device Pros, LLCMedical Device Pros, LLCMedical Device Pros, LLC
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1-321-210-5633

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Engineering Consultants for the Medical Device Industry

Engineering Consultants for the Medical Device IndustryEngineering Consultants for the Medical Device IndustryEngineering Consultants for the Medical Device Industry
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Why Choose Us?

Dwight Back and Michele Gardill

Our global Experience, Our Team

With over 60 years combined experience, & our team of trusted associates, we are medical device engineering consultants you can trust.  Dwight Back, Ph.D. & Michele Gardill, P.E., MBA, understand what successful medical device development takes:


  "We've been through the product life cycle--globally.  From idea to successful launch!" 

See What Our Clients Say
medical device engineering consultants

OUR SERVICES

If you are a manufacturer, consultant, physician/inventor, or other person who designs, develops, manufactures, or troubleshoots medical devices, we can help you.  


We do patent applications, design & prototyping, ASTM testing, & manufacturing support--even in a crisis situation.   Our data analyses in FDA submissions have withstood FDA scrutiny.  

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Our portfolio

We are especially proud of our recent cardiology product development work.  


We've helped launch Class I, Class II, and Class III devices.  We are proud of our successes--with patents, new designs & testing, materials recommendations, and devices APPROVED by FDA & elsewhere.  

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WHAT OUR CLIENTS SAY ABOUT US

new test method

TEAMWORK ON A MEDICAL DEVICE BREAKTHROUGH

TEAMWORK ON A MEDICAL DEVICE BREAKTHROUGH

"Thanks for all the hard work!  Your correlations clearly demonstrate superiority of the [Class III medical device]..."  


       --Fellow Consultant/Collaborator on Global Project


* * * * *

TEAMWORK ON A MEDICAL DEVICE BREAKTHROUGH

TEAMWORK ON A MEDICAL DEVICE BREAKTHROUGH

TEAMWORK ON A MEDICAL DEVICE BREAKTHROUGH

"Wow...Very impressive.  Kudos and Congrats


             --U.S. Research M.D.


* * * * * 

CLASS III PMA APPROVAL

TEAMWORK ON A MEDICAL DEVICE BREAKTHROUGH

CLASS III PMA APPROVAL

 "I want to thank you for all your help, understanding and patience...over the years....you always worked as a team to figure out a way to move forward and overcome...Again, thank you!!!"


    --CEO and President of a Medical Device Company


* * * * *

ENGINEERING advice

specification for MEDICAL DEVICE TESTING

CLASS III PMA APPROVAL

"THANK YOU!  This is excellent."


     --CEO at a Medical Device Company


* * * * *

specification for MEDICAL DEVICE TESTING

specification for MEDICAL DEVICE TESTING

specification for MEDICAL DEVICE TESTING

"Thank you for the excellent directions on what you required within the quote."


 --Test Lab Manager (U.K.)


* * * * *

Crisis Mitigation

specification for MEDICAL DEVICE TESTING

specification for MEDICAL DEVICE TESTING

"Apparently you don't take weekends off! ...very impressive.  This model is extremely inclusive reflecting the total system and data to date."


         --Manufacturing Engineer at a Fortune 500 Biomedical Company


* * * * *

What Our Clients Say

Our Certifications & Memberships

Professional Engineer
Chemical Engineer
Engineering Honor Society

Crisis Mitigation Services

Crisis Mitigation like an umbrella in a storm

help when you need it most

483 Letter from FDA?

Looming Corrective Action?

Likely Product Recall?


You need highly experienced, data-driven guidance.  You need Medical Device Pros, LLC.

Learn more now
teamwork during a crisis

CRISIS roles we fulfill

Resolving a crisis requires strong leadership and responsive support.


At Medical Device Pros, LLC, we offer both: Crisis Mitigation leadership, and top-notch Data Analysis & Troubleshooting support.

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Complimentary Information

Click & receive our free guide "My Medical Device: Class I, II, or III?"

We welcome inquiries from other Medical Device Industry Consultants.

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