Day

August 21, 2011
Recipient: Spinetronics, LLC .Product: Antalgic-Trak Date: 7/25/2011 Violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures....
Read More
Company: Blood Bank Computer Systems, Inc.Date of Enforcement Report 8/17/11 Class ll: PRODUCT Blood Bank Computer Service (BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M. The device is a software application used by blood banking firms to track donor information at remote sites to eventually link up with the Primary Application that is linked to...
Read More

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.