Hi RAPS Folks,
My company manufactures and markets various different types of chemical and electronic temperature monitors. Our products tend to fall on the borderline of being classified as regulated medical devices or not, depending on how they are marketed and used in the US (and other geographies). As a result, we market a mix of regulated and unregulated products.
Previously, we worked with a consultant who was a retired FDA official. She had a great understanding of the regulations surrounding temperature monitoring of blood, drugs/vaccines, and other products, partly because she helped to write them! Unfortunately, she has retired from consulting, leaving us looking for a replacement.
So the question is, do you know or can you recommend a consultant with experience regarding FDA regulation of temperature monitors and/or time-temperature indicators?
Feel free to respond here or send me an email at
rob.molinaro@zebra.com.
Thanks!
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Robert Molinaro RAC
Senior Regulatory Affairs Manager
Kinnelon NJ
United States
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