FDA CDRH 510(k) Guidance for PACS – OBSOLETE

As of 7/27/2000 this document is obsolete as the ” Guidance for the Submission OfPremarket Notifications for Medical Image Management Devices” was issued to replace it. This remains on the site for historical reference and background only but SHOULD NOT BE USED FOR PREPARING FDA SUBMISSIONS.

FDA CDRH’s Office of Device Evaluation’s second version of “Guidance for the Comment and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices” issued August 1, 1993. This version allowed for use of lossy compression. Medical devices.

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

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