Replies to post #86752 on Decision Diagnostics Corp (DECN)

[pumper_stumper]

I wasn't aware that there was an industry certification for "Program Manager for Medical Device's. Can you link me to info on how one achieves this title?

"The guy has been a Program Manager for Medical Devices "

[IPwatcher]

Would you mind showing the proof for the statement above? The guy has been a Program Manager for Medical Devices and in-vitro diagnostic products for over 40 years. Is the statement above claiming that in 40+ years Mr. Berman has never ever succeeded in achieving FDA clearance for any product(s)?

A search of this FDA website shows there are no 510Ks that were filed by DECN, and instead DECN is relying on inherited 510Ks filed and awarded to different corporate entities (Shasta, and HMD biomedical that I have been able to identify thus far). Unless Berman has been moonlighting somewhere else, therefore, it is safe to say that he has not been responsible for a successful 510K submission during the course of his tenure at DECN.

If he has been moonlighting, or is claiming responsibility for 510K submissions prior to his tenure at DECN (which would probably come under the category of archeology now, giving the elapsed time and amount that has changed in the intervening period) it should be a simple matter to quote the K numbers of the 510K submissions that Berman is claiming credit for. If they exist.

Notwithstanding, any such submissions were not completed by DECN, Pharmatech, nor the Bio co, as none of these entiries are present in the list of organisations that have been granted 510K approvals.

[rawman]

So now it has been officially confirmed and PROVEN, contrary to CEO Keith Berman's contrived BS, Berman has NEVER actually overseen a full FDA product approval review!

OK! Allow me to add a very germane qualifier!

So now it has been officially confirmed and PROVEN, contrary to CEO Keith Berman's contrived BS, Berman has NEVER actually overseen a full FDA drug or medical device approval review, while either owning PharmaTech Solutions or being the CEO of DECN. That oughta cover about the last twenty years.

BTW, given the indignant response, can it be proven Berman has EVER led a project/orogram team that was successful in being granted an FDA approval for anything? What was the drug or device?

[loanranger]

"Is the statement above claiming that in 40+ years Mr. Berman has never ever succeeded in achieving FDA clearance for any product(s)?"
The assertion was regarding an approval, not a clearance. Are they the same?
If he has been responsible for getting a medical device approved, what device was it?