SilverHawk said:
I hope Mr Ed does not mind that his matrix is shared by all.
This document is alreday spread over the web, so I think this is not a problem at all.
Some remarks to this matrix:
The use of the DIS and FDIS in the column headings (and within the matrix) are typographical errors.
The content of the chart is from the final, approved versions of ISO 13485:2003 and ISO 9001:2000.
Ed you writes in his table, that he did not find the regulatory definitions for "active implantable medical device", "active medical device" and "advisory notice".
These definitions are taken from Article 1 of the the
COUNCIL DIRECTIVE 90/385/EEC
The term "advisory notice" is originally defined in EN 46001 and also
referenced in the
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
I have checked this matrix, and I agree in the most points, but a some places in the comments I think the terms "QS Reg" and "Standard" are mixed up.
p.s.: there are also some typos in the ISO 13485:2003 Standard too (eg. in the comparison Comparison-Table Annex B Section 7.5.5 should read "Preservation of PRODUCT" (not property)