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!"
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.
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.
"Thanks for all the hard work! Your correlations clearly demonstrate superiority of the [Class III medical device]..."
--Fellow Consultant/Collaborator on Global Project
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"Wow...Very impressive. Kudos and Congrats
--U.S. Research M.D.
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"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
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"THANK YOU! This is excellent."
--CEO at a Medical Device Company
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"Thank you for the excellent directions on what you required within the quote."
--Test Lab Manager (U.K.)
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"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
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483 Letter from FDA?
Looming Corrective Action?
Likely Product Recall?
You need highly experienced, data-driven guidance. You need Medical Device Pros, LLC.
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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