Implementing Design Controls for Device Manufacturers
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Implementing Design Controls for Device Manufacturers
Design controls are a part of an inclusive quality system that covers the life of a device from the development of device requirements through design, production, distribution, use, maintenance, and ultimately, obsolescence. Design control also applies to the changes to the process design including those occurring after a device has been offered to the market.
This guidance document applies to the design of the medical devices including new designs as well as changes to the existing device designs.
Summary of Requirements
The manufacturer of any class II and class III device as well as of some class I devices should establish and retain procedures to control the design of the device to ensure compliance with regulatory requirements.
The FDA guidance document details the requirements for:
- Design and Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Design History File (DHF)
Related Training:
Design Controls: What to Know When it Comes to FDA Regulated Industry?
Learning Design Controls through Review of FDA 483 Observations
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