Medical Industry - Nominal Quality Requirements

[agile_qa]

Hi All! First post here. I have, in response to a customer request, been asked by management to have knowledge of the "quality nominally expected of products in the medical industry." No other instructions are forthcoming. I suspect what is needed is expected first pass yields, etc.
Any help in this matter would be greatly appreciated.

[Al Rosen]

Originally Posted by agile_qa

Hi All! First post here. I have, in response to a customer request, been asked by management to have knowledge of the "quality nominally expected of products in the medical industry." No other instructions are forthcoming. I suspect what is needed is expected first pass yields, etc.
Any help in this matter would be greatly appreciated.

Hi agile:


Since your in Canada, start with ISO 13485 and look at the Canadian Therapeutic Products site http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/

To answer the question. The products have to work and not harm anyone.

[M.Taghavi]

Hi Agile,

The answers for questions you have, are too long to be put in a couple of lines.
Follow the site address which Al has suggested. After that, in case yau had more queries I will appreciate helping you. (I am an ISO13485 lead assessor)

[wrodnigg]

Originally Posted by Al Rosen

Since your in Canada, start with ISO 13485 and look at the Canadian Therapeutic Products site http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/

In addition to the standard, the ANSI/AAMI/ISO Guideline 14969:200x (currently available as draft, just search for 14969) "Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003" gives plenty of information to implement a 13485 QMS.