Devicemaker Quality Compliance Using Risk Management to Improve Design Controls
Devicemakers must establish strict design control procedures as part of their quality management system. And, they must create a risk management system to satisfy the FDA and international regulators.
In order to have an effective risk management system, you’ll need to know:
How to look at design control from the risk management perspective and vice versa
Specific international standards and FDA regulations for both systems
Areas where the activities in one system support, or even complement, the requirements in the other system
How to use product safety standards to improve efficiency
Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls shows you where design control and risk management requirements overlap so you can serve both with one integrated effort. You’ll learn:
Which U.S. and international standards address each of the systems
Where FDA regulations differ from European standards
The standard flow of design control procedures
The four phases of risk analysis
How to define the authority and responsibility of people involved in design
Devicemaker Quality Compliance shows you how to create a robust quality operation and meet the goals of both your quality management system and risk management system.
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PDF Edition — $177
Who Will Benefit
Design Engineering Managers
Production Managers involved in production and process changes
Regulatory Affairs Managers
Risk Management Professionals
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