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Eyal Lerner Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

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