Risk Management in the Medical Devices Industry
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Risk Management in the Medical Devices Industry

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Webinar Title: Risk Management in the Medical Devices Industry

Risk Management in the manufacturing of Medical Devices has come to the forefront lately.

Most of the larger medical device organizations are implementing Risk Management. ISO 13485 requires organizations to manage risk in 7.1: Planning of Product Realization. It also cites ISO 14971 which is a standard that provides guidance for Risk Management in Medical Devices.

What are the tried and true methods at the disposal of medical device organizations? What is Advanced Quality Planning, FMEA and Control Plans as they apply to medical devices? How does one look at project risk and manage manufacturing risk?

Join Omnex and SGS to understand best in class processes and methods for the medical devices industry including Risk Management software.

Webinar Agenda

  • Overview: ISO 13485, Advanced Quality Process and Phase Gate Reviews Risk Management
  • AQP Core Activities and Deliverables
  • Implementing AQP using AQuA Pro software - saving money and time in New Product Development

System Requirements


PC-based attendees
Required: Windows® 7, Vista, XP or 2003 Server

Mac®-based attendees
Required: Mac OS® X 10.6 or newer

Mobile attendees
Required: iPhone®, iPad®, Android™ phone or Android tablet

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