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From GlobalCompliancePanel
Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel
...ply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001.
Areas Covered in the Session:
* Principles of ISO 13485: 2003
* ISO 9001 & ISO 13485 Differences
* Risk Management & ISO 14971
* FDA's MDR's & EU Vigilance
* Design
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