Application of Risk Management - ISO 14971:2007(E) Medical Devices

[jem63]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Hi guys

I would like to provide my web search results before just contents and 'Foreword + Introduction' session.

*** DEAD LINK REMOVED ***
(Several month ago, I can download Eng version, but now only to read)

I believe this is not offense copyright.
If do please remove this attachment

Bwana

If you look within page 'ii' it states
"This ISO document is a Draft International Standard and is copyright-protected by ISO."

 

[Valery]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Hi Bwana,

I failed to find a page "ii". Coud you help me to find it?

Thank you in advance.
Regards,
Valery.

 

[wrodnigg]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Among others I can mention: Danish Standards Association and IHS.

Another source for cheap standards is the Standards Institute of Luxembourg, I have already purchased some standards there (EN, FR, DE), and they are often cheaper than the Austrian, German, ISO or AAMI standards institutes.

 

[wrodnigg]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Gert,

FMEA is your friend.

yes and no.

There is a good article on (broken link removed) from the MDDI Magazine.

I would say, "some kind of risk analysis" is your friend, just follow the process described in the 14971 Standard (Annex B), and choose your preferred methodology for each phase (the annexes also contain introductions to them, best to start with Annex D)

 

[wrodnigg]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Design is already done when I start the mfg. process.
Should this risk assessment be the responsibility of the design activity?

Risk Management should be part of the wohle product lifecycle process, starting with the concep phase.

In the Standard 13485, Risk Management is addressed in the planning of product realization phase (clause 7.1). This is the entry point into reisk management for each product/device.

 

[bio_subbu]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Hi,

i am new in this forum, i have seen in ISO 14971:2007 latest revison standard, it is quit good, and more explanation about expecially In vitro diagnostics, but i don't know that how to start with. can any one help me out.

Thanks
subramaniam

 

[Ajit Basrur]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Hi,

i am new in this forum, i have seen in ISO 14971:2007 latest revison standard, it is quit good, and more explanation about expecially In vitro diagnostics, but i don't know that how to start with. can any one help me out.

Thanks
subramaniam

Welcome to the Cove, Subramaniam.

Pls note that I have deleted your email address.

 

[Al Rosen]

Re: ISO 14971:2007(E) Medical devices — Application of risk

yes i have the copy of ISO 14971:2007

Please don't post it here as it is copyrighted material. (broken link removed)

 

[minaadel]

Re: ISO 14971:2007(E) Medical devices — Application of risk

thx sir for ur valueable info
plz i need help in using this standared plz i need a model for risk analysis according to iso 14971-2oo7

 

[Ajit Basrur]

Re: ISO 14971:2007(E) Medical devices — Application of risk

thx sir for ur valueable info
plz i need help in using this standared plz i need a model for risk analysis according to iso 14971-2oo7

Welcome to the Cove minaadel

Pls be very specific in your queries to get appropriate responses.