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Home > Archive > Electrical code Compliance > February 2007 > QA System & Risk Management Software
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| Author |
QA System & Risk Management Software
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| Gisly@NNL 2007-01-06, 8:28 pm |
| Hi
Can anyone recommend me any software for handling a Quality system in
accordance with ISO 13485 for medical device companies?
I'm also interested in software for handling Risk Management in
accordance with ISO 14971 / IEC 60601-1 3'rd edition.
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| Paul E. Bennett 2007-01-06, 8:28 pm |
| Gisly@NNL wrote:
> Hi
>
> Can anyone recommend me any software for handling a Quality system in
> accordance with ISO 13485 for medical device companies?
>
> I'm also interested in software for handling Risk Management in
> accordance with ISO 14971 / IEC 60601-1 3'rd edition.
If you have a budget for this software then visit <http://www.mks.com/>
which is a series of products that will deal with the full lifecycle
management of your contracts, requirements specifications, technical
specifications, hardware schematics and software design and coding
documentation. This can include problem reporting and tracking as well as
versioning with multiple development strands.
Others may suggest free or inexpensive packages that do part of the job.
--
********************************************************************
Paul E. Bennett ....................<email://peb@amleth.demon.co.uk>
Forth based HIDECS Consultancy .....<http://www.amleth.demon.co.uk/>
Mob: +44 (0)7811-639972
Tel: +44 (0)1235-811095
Going Forth Safely ..... EBA. www.electric-boat-association.org.uk..
********************************************************************
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| mmantunes@gmail.com 2007-02-28, 8:25 pm |
| On 5 jan, 14:59, "Gisly@NNL" <s...@nordicneurolab.com> wrote:
> Hi
>
> Can anyone recommend me any software for handling a Quality system in
> accordance with ISO 13485 for medical device companies?
>
> I'm also interested in software for handling Risk Management in
> accordance with ISO 14971 / IEC 60601-1 3'rd edition.
There=B4s Dyadem FMEA for Medical Devices - www.dyadem.com
--
Best regards,
Marcelo de Moraes Antunes - mantunes@ipt.br
Medical Electrical Equipment DIvision
Electrical and Optical Equipment LAboratory -
Institute for Technological Research - IPT - S=E3o Paulo - Brazil
Fone +55 (11) 3767-4820 Fax +55 (11)3767-4007
Medical Electrical Information Website: http://www.electromedicalinfo.com/
MSN: marcelo_antunes@hotmail.com
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