Replies to post #89335 on Decision Diagnostics Corp (DECN)

[IPwatcher]

(There are 2 normally much longer formal stages of development between feasibility and launch! Just saying).

Please provide proof of expertise in these areas. Any proof of expertise. Thank you.

I already did.
The link is included is a massively condensed layman friendly version of the ISO13485 medical devices regulatory approval process, which itself mirrors the FDA PMA/510K regulatory device approvals process outlined in 21CFR part 820.

This is public information. I linked to a commercial digest rather than the raw regs as these are a bit esoteric.

But here you go (below).
By the way, 'feasibility' generally refers to the part of the research phase that precedes the implementation of "Design Controls" at which point the "Formal product Development" phase commences.
There is a requirement to conduct and documant a formal Product Design review upon exiting feasibility and entering Design control/ Development phase.
It is also a requirement these days to codnuct a system risk analysis and update this at each design stage. FMEA is the usual method employed.
Even with an EUA you still need the validation and verification activities, associated with the "Design output" stage review. And if DECN are only now starting to do feasibility testing, they are a VERY long way from that stage gate!


Read at your leisure:

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices