Module 14 2022
14/03/2022
What is Design Control?
”…an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances.”
”…make systematic assessment of the design an integral part of development.”
”…increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.”
FDA Design Control Guidance
The Organisation for Professionals in Regulatory Affairs
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What is Design Control?
...a common sense approach
Proof that you have designed a safe product that meets user needs and requirements!
The Organisation for Professionals in Regulatory Affairs
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