Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 14696?

[qualitygoddess - 2010]

I have searched a bit through the Cove, and looked at some of the active threads for this forum on ISO 13485. I'm a novice just looking for someone to point me in the right direction.

Which are the standards that I should read to get an understanding of ISO 13485 and any guidance standards? 13485:2003 and 14696?

Can anyone recommend a good overview book or maybe a video? Something that puts the standard into language that a novice can understand? Kind of like what we have out there for ISO 9001:2000.

Thanks!!

 

[Gert Sorensen]

Re: Quick Overview of the Standards for Medical Devices

I have searched a bit through the Cove, and looked at some of the active threads for this forum on ISO 13485. I'm a novice just looking for someone to point me in the right direction.

Which are the standards that I should read to get an understanding of ISO 13485 and any guidance standards? 13485:2003 and 14696?

Can anyone recommend a good overview book or maybe a video? Something that puts the standard into language that a novice can understand? Kind of like what we have out there for ISO 9001:2000.

Thanks!!

Basically, 13485 is 9001 for medical devices with a few ammendments about risk management - and compliance to Canadian regulations and FDA-rules. I'm sure Al has more on the subject.... But, in all honesty, the place to learn about 13485 in a practical sense is here. The Cove has some really knowledgeable participants, and they are more than willing to share. Do browse through the forums for 13485 and FDA, it will tell you more than any book (at least, so I guess).

 

[Synergy]

Re: Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 1469

Hello,

Al beat me to the punch with ISO 13485 translated in plain english, but I have a couple of other sites I have been using as well, found at

http://www.medical-devices-faraday.com/links_sources.html

Regards
Synergy

 

[Doug Tropf]

Re: Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 1469

I have searched a bit through the Cove, and looked at some of the active threads for this forum on ISO 13485. I'm a novice just looking for someone to point me in the right direction.

Which are the standards that I should read to get an understanding of ISO 13485 and any guidance standards? 13485:2003 and 14696?

Can anyone recommend a good overview book or maybe a video? Something that puts the standard into language that a novice can understand? Kind of like what we have out there for ISO 9001:2000.

Thanks!!

I am assuming you meant 14969 - I referred to this 13485 guidance document regularly in preparing our organization for certification.

 

[amjadrana]

Re: Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 1469

I used ISO TR 14969 as guidance. This guidance is used by the registrars as well to audit the ISO 13485 systems. I would recommend to use this guidance along with the ISO 13485 standards for implementation.

Another good book is ISO 13485 Essentials from CSA. I used the previous version of the book and found it to be very well written.

http://www.csa-intl.org/onlinestore/GetCatalogItemDetails.asp?mat=2417913&Parent=4310


Amjad Rana

 

[Synergy]

Re: Quick Overview of the Standards for Medical Devices - ISO 13485:2003 and ISO 1469

Hello,

I forgot to provide an excellent overview document posted by BSI, it free but requires registration.
http://www.bsiamericas.com/MedicalDevices/UnderstandingISO13485.xalter?print_only=1

Regards
Synergy