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).

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

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