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Learn about the latest Quality Management System requirements for medical devices, known as ISO 13485:2016.  The requirements apply to organizations regardless of their size and regardless of their type except where specifically stated.

The discussion will include:
  • ISO 13485 Overview
  • Review Major ISO 13485:2016 Changes
  • FDA Case for Quality Initiative
  • eQMS and Design Control Harmonization
  • Medical Device Audit Readiness Plan
  • Live Q & A session
About the Presenters:
Amir Pirastehfar

Director of Product Lifecycle Management (PLM) Services and Solutions at USDM Life Sciences He focuses on support and growth of PLM services. Amir has 20 years of technology, systems analysis, project management and product management experience.For part of his career, Amir owned the global Laboratory Information Management System (LIMS) at one of the largest biotech companies in the world. He also led all IS activities for implementation and enhancements of their CRM System.

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