FDA Inspection Observation Summary for 2015.

FDA issued “2015 Annual FDA Medical Device Quality System Data Inspections, FDA Form 483 Observations, and Warning Letter Citations”. The full report is at the link provided.

This report identifies numbers of observations and inspections by country as well as obervations by Quality subsystem. FDA noted that the number of Foreign inspection has increased. Production and Process Controls and CAPA continue to be the most frequently cited.

The most frequent Design Control citiations were Design Validation by a large margin then Design Changes followed by Design Verification with a much lower number related to other elements of Design Control.

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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