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Medical Devices / Inspections and Audits

Qview Medical Cited for Design History File Deficiencies

May 17, 2018
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Qview Medical, a medical device manufacturer in Los Altos, California, received a Form 483 for design history file deficiencies the FDA found during a January inspection.

The agency noted that the firm’s design history file did not demonstrate that its design was developed in compliance with requirements.

The company did not conduct design reviews at the appropriate stages of the design and development process. Its QVCAD System Version 3.3 design and development plan lacked formal design review documentation for its concept and development phases, both of which were completed.

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