Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

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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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Who Will Benefit

  • Quality Managers
  • Design Engineering Managers
  • Production Managers involved in production and process changes
  • Quality Engineers
  • Design Engineers
  • Manufacturing Engineers
  • Regulatory Affairs Managers
  • Risk Management Professionals

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