EN ISO 14971:2012 Impact Assessment
Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net Link to Sam Lazzara's EN ISO 14971:2012 Flow Chart Still trying to figure out what to do about EN ISO 14971:2012? The ASQ Biomedical Division just published an article I wrote called Risky Business - Demystifying EN ISO 14971:2012 . To view the article, go here . Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net Summary EN ISO 14971:2012 became a European harmonized standard on August 30, 2012. The normative content is still in accordance with ISO 14791:2007. However, the relationship between ISO 14971 and the European Directives has changed as described in Annex ZA, ZB and ZC. Compliance with the normative clauses in ISO 14971 does not ensure conformity with the Essential Requirements (ERs) of the Directives. The Z Annexes list “content deviations” between ISO 14971 and the ERs. B