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Posted On: 03/02/2023 9:32:11 AM
Post# of 495
Lets set the record straight! CEO Brian Thom has been instrumental IMO to reach out to experts with proven track records dealing with FDA applications.....
Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the company’s manufacturing process, which results will be included in its final PMA application.
Do your own d/d! My d/d tells me RCA is the regulatory consultant with a proven record of FDA applications.
https://www.rcainc.com/medical-device/regulat...l-support/
$5-$10+
Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the company’s manufacturing process, which results will be included in its final PMA application.
Do your own d/d! My d/d tells me RCA is the regulatory consultant with a proven record of FDA applications.
https://www.rcainc.com/medical-device/regulat...l-support/
$5-$10+
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