Customed Inc.

Customed Inc.
Product: medical devices, including convenience packs for surgical procedures
Date: 1/9/2015

Failure to validate the defined user needs and intended uses of the (b)(4) used as part of the quality system according to an established protocol, as required by 21 CFR 820.70(i). Specifically, your firm implemented (b)(4) to track product inventory (incoming materials, finished/released products and quarantine items), however the software was not validated. In addition, the status of lots of finished products and incoming materials in the warehouse failed to match the (b)(4) system inventory.

Your firm?s response dated August 21, 2014, is not adequate. Your firm initiated CAPA (b)(4) to prepare a software validation protocol, however, you failed to initiate a corrective action to identify and address pertinent quality system and production software that have not been appropriately validated. Further, your firm failed to provide the executed (b)(4) validation protocol and summary report for review.

FDA District Office:San Juan Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at 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.