John F. Murray, Jr, joins SoftwareCPR as a partner

(January 7, 2019)— John F. Murray, Jr, of Mount Airy, MD USA, has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a partner. John retired from the US Food and Drug Administration in December 2018 after 32 years of federal service.

For 25 years at FDA, John focused on FDA regulated software and computer systems. John is an expert in FDA software regulation, software policy and software guidance. He participated extensively in national and international software standards development. John started his FDA career in the Office of Science and Technology, then he spent 15 years in the Office of Compliance finally completing his FDA career as a “startup” member of the FDA’s Digital Health Unit.

As a partner at SoftwareCPR he looks forward to continuing to share his expertise with industry through consulting and training. For more information click softwarecpr.com or call 781-721-2921.

John will be on faculty for our upcoming Being Agile & Compliant Public Training Course, Feb 18-19, 2019, in Tampa, FL USA.

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba 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. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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