Sam Lazzara's Medical Device Quality Central Blog

Damn standards! It is hard enough to keep up with the latest revisions, but even if you achieve that, who has time to actually read them to see what the changes are? Is it necessary to get all of the "different" versions of what appears to be the same standard? ISO vs. EN ISO (harmonised or not) vs. BS EN ISO vs. ANSI/AAMI/ISO .... YUCK!  Here is what I do. 1. Purchase ANSI/AAMI/ISO standard from AAMI. Why purchase from AAMI? Because they are the most economical source I have found for many medical device ISO/IEC standards if you purchase their AAMI Standards on CD Complete Collection . 2. Look at "Glossary of equivalent standards" in the ANSI/AAMI standard to see if the ANSI/AAMI version you have is "Identical" to the corresponding ISO/IEC standard. Most often, it is identical. Do not buy the pure ISO/IEC version if the ANSI/AAMI version is identical - you would be wasting your money. 3. To prove equivalence between the "normativ...

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Much can be learned by reading medical device labeling and promotional materials - particularly Instructions For Use (IFUs) and other safety-related information.  The IFUs of your competitors or quasi-competitors are excellent tools to facilitate product development and risk management. However, when it comes to finding labeling content on the internet, beggars cannot be choosers. Here is what this beggar has found so far: Abbott Vascular IFUs Boston Scientific Products Keep clicking and you should find "Prescriptive Information" and sometimes "Directions For Use". You can even sign up for email updates when the "DFU" is revised.  Product Safety Information How helpful! Cook Medical CR Bard No IFUs - just general product information.   ev3/Covidien Product Catalogs ev3/Covidien "Neuro" Products (...