Hi Axel. It's nice to read you ;-)
Some years ago I tried to get a CE2 certificate for a product
that I was developing. The cost of the certification was about
20000€. But after that, the certificated product should be
inscribed on the sanitary agency of each European country where
you want to sell it. It's not a stamp, but 28 :-(.
That was about 4 years ago; I don't know if things will be
different now.
What the certification agency inspects is the reliability of the
product; specifically, that it can't make the doctor make a bad
diagnosis because of malfunctions or inaccuracies of the software.
The certification doesn't appreciate the existence or not of
"extra features". So, having a certified product doesn't guarantee
more quality than a not certified one. As I told previously, the
only point of this is that for some public healthcare systems the
use of CE2 / FDA certified software is compulsory.
Best regards.
On 04/11/2017 08:18 PM, Axel Braun
wrote:
That would be the luxury version. If you have the choice between
nothing and an uncertified software, what would you do?
Would be interesting to get the requirements that need to be
fulfilled in order to judge whether there is a quality difference
(which I doubt) or just a missing stamp.
Schöne Grüße
Axel
--
Written from cell phone - excuses for typos
Am 11. April 2017 11:27:02 MESZ schrieb
Edgar Hagenbichler <address@hidden>:
We need somebody experienced with certification, an offer
for programming and approving it to the legal bodies, a
timetable and then we can start crowdfunding.
Best regards
Edgar
Von meinem iPhone gesendet
Many products, like OsiriX, have almost the same
functionalities in the free-"not clinical" version and
in the "not free"-FDA compliant version. The point that
legally you can't use a not certificated PACS for
diagnostic purposes. Many people make diagnostics with
these not certified PACS, but you risk to have legal
issues if a bad diagnostic is made when using them.
Public hospitals in Europe won't accept any PACS without
the CE2 certification, equivalent to FDA.
Certification can be made, but is a long and expensive
process. Yes, we need a sponsor :-(
Best regards.
On 04/11/2017 08:49 AM, Axel
Braun wrote:
This may be, indeed.
A formal act. And a national institution. Potentially
impossible for free software to get this approval, as
some money is involved. Anyone standing up for
sponsoring?
Schöne Grüße
Axel
--
Written from cell phone - excuses for typos
Am 10. April 2017 20:17:04 MESZ
schrieb "Leonardo M. Ramé" <address@hidden>:
I think what qualifies as diagnostic are those
that counts with FDA approval.
--
Leonardo
El 10/04/17 a las
14:57, Axel Braun escribió:
Interesting question: what makes a
viewer 'suitable for production ' or diagnostic?
Schöne Grüße
Axel
--
Written from cell phone - excuses for typos
Am 10. April 2017
18:17:13 MESZ schrieb Khurram Shahzad <address@hidden>:
Dear All,
Thank you very much for the valuable
experiences and advice.
I have tried almost every DICOM Viewer
discussed so far and it is revealed
that all of them have certain
limitations.
By the way, what do the lines "Not for
diagnostic purpose" and "Clinically not
suitable" (highlighted for all these
viewers) mean? Are these viewers not
production-ready? Or, we should not use
them in production? If yes, these
open-source viewers are useless for
production and are we left with no
option other than costly/non-free
viewers?
Best Regards,
Khurram.
|