Test Manager Completed Course on FDA Compliance

Recently, Logikos' Manager of Test Services Tim Bottoms completed a course focusing on the FDA's General Principals of Software Validation (GPSV) and its application to medical devices. The program, provided by the American Association of Medical Instrumentation (AAMI), was held in Washington, DC. The 3 day course--titled "Software Validation Requirements & Industry Practice"--provides regulatory affairs experts, quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the software validation requirements of the FDA's Quality System regulation while offering information on how to implement an effective software validation program. This was the first occurrence of this Software Validation course since it was expanded to 3 days in order to focus more attention on production and quality system software. The newly expanded course included a discussion on Medical Device Software Risk Management and how it relates to ISO 14971; an explanation on cyber security for networked medical devices containing Off-the-Shelf (OTS) software; an update on Part 11; and tips on production and quality system software. The knowledge gained by Tim will greatly help Logikos to help our customers whose products and processes must meet the FDA's requirements. Only a handful of people in Northern Indiana have completed this program. Read more about this course at AAMI's website (www.aami.org).