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4.00 RAC

Medical Devices: Risk Management

This course discusses risk management for medical devices as described in ISO 14971:2007, Medical Devices—The application of risk management to medical devices, the product safety standard put forth by the International Organization for Standardization (ISO).

4.00 RAC

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Risk management is a process for identifying, evaluating and mitigating risk. For medical devices, this means product safety, including risks associated with harm to people and damage to property or the environment. Risk management has become an integral part of medical device design and...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design