Risk Management in the Medical Devices Industry
Webinar Title: Risk Management in the Medical Devices
Risk Management in the manufacturing of Medical Devices has come to the forefront
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.
- 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
Required: Windows® 7, Vista, XP or 2003 Server
Required: Mac OS® X 10.6 or newer
Required: iPhone®, iPad®, Android™ phone or Android tablet