Recipient: CuraeLase, IncProduct:CL 1000 IR Laser System Date: 12/9/2011 Quality System Regulation Concerns We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820): 6. Failure of the DMR for each device type to include or refer to the location of the device specifications, including software specifications, as required by...Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
Leave a message and we will contact you to schedule: