Medical Development Research Inc.

Failure to review and evaluate all complaints and maintain a record of the reason no investigation was made and the name of the individual responsible for the decision not to investigate; failure to maintain records that demonstrate that each batch, lot, or unit of device meets in-process or finished device specifications; failure to validate and document all processes and/or off-the-shelf software used to operate and control equipment; failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications; failure to maintain and implement written Medical Device Reporting procedures; and failure to report within 30 days information that suggests that a device has malfuntioned.

Failure to validate and document all processes and/or off-the-shelf software used to operate and control equipment, which cannot be fully verified by subsequent inspection with a high degree of assurance, which is approved according to established procedures, as required by 21 CFR 820.75(a) . For example, polishing validation fails to document adequate results for single and multi-piece lenses including polishing, tumbler speed, duration, and re-polishing of reworked lenses, off-the-shelf software use for the operation of the DAC lathe and to trend quality data related to nonconformances (FDA 483, Item #6 & #9).

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
Registration Link

Corporate Office

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