Ampronix, a Top Master Distributor for Sony Medical, provides Sales, Service & Exchanges for Sony Surgical Displays, Printers, & More. Rely on Us for Expert Support Tailored to Your Needs. Email info@ampronix.com or Call 949-273-8000 for Premier Pricing.
View all The Jacobus Report Blog Posts
Phil Jacobus has been involved in health care since 1977, when he visited China to sell equipment. He has done business in 35 countries and still travels extensively. Phil is active in charity, helps rural clinics and always tries to help DOTmed users when he can.
Phil is a member of AHRA, HFMA, AAMI and the Cryogenic Society of America. He has contributed to a number of magazines and journals and has addressed trade groups.
Phil's proudest achievement is that he has been happily married to his wife Barbara since 1989, who helped him found DOTmed in 1998.
![]() ![]() Leon and Philip each bring up good points about Chinese medical products. Additionall,do they pay the medical device tax? Are they ISO cerified and their methodologies and processes compliant?
|
|
You Must Be Logged In To Post A CommentRegisterRegistration is Free and Easy. Enjoy the benefits of The World's Leading New & Used Medical Equipment Marketplace. Register Now! |
Leon Zebrick
Chinese Products
July 10, 2015 07:01
In the United States, physiological monitors are considered Class II medical devices and are regulated as such by the FDA. The FDA requires premarket notification, GMP in production, and postmarket surveillance. A market price-point of $700 would suggest to me that none of the above would be in place. If that’s true, I wonder then if use of the device in commercial application in the US would even be legal. Considering also the amount of litigation surrounding medical device related incidents, I couldn’t recommend purchase to my employer.
to rate and post a comment