Sunday, February 22, 2009

FDA expectation from you during Design Control portions of Inspections

Subsystems interacting with The Design Control Process
  • Management Controls
  • Production and Process Controls
  • Corrective and Preventive Action
  • Document and Record Control
  • Labeling and Packaging Control
  • Risk Management
  • Change Control


Design control requirements

Your Firm must have a 21 CFR 820.30 compliant design control process prior to submitting a 510(k), as well as during IDE and PMA data collection. FDA WILL LOOK AT THIS!!!! In the last year several client firms have had FDA heavily examine whether or not their design control was compliant prior to a submission taking place.

Concepts of Design Control

  • Design and Development Plan
  • Design Input & Output
  • Design Review
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)

Risk Management Process ISO 14971

For more detailed explanation attend the training click here

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