Consultants | Robert Handren

Mr. Robert T. Handren, Jr., has over 40 years of medical device regulatory affairs and radiation safety experience including 16 years as an independent consultant with domestic and international clients, 15 years at FDA’s Center for Devices and Radiological Health (CDRH), 11 years with the U.S. Army Medical Department and 18 months with the Lawrence Livermore National Laboratory.

Mr. Handren has performed, managed and supervised the performance of hundreds of site and plant inspections, domestic and foreign, for compliance with good manufacturing practice, quality control, health physics and safety requirements while representing the FDA and the U.S. Army Medical Department. Further, he has reviewed, managed and supervised the review of thousands of applications, reports and submissions required by the FDA for medical devices and radiation producing electronic products. While at FDA, he successfully managed the FDA’s Compliance and Medical Device programs regulating over 1,300 laser, sun lamp and mercury vapor lamp manufacturers world-wide.

Throughout his long career, he has provided regulatory compliance and control program advice to hundreds of regulated manufacturers, state, local and foreign governments. He consistently received awards and recommendations for promotion while working for the government. He is an accomplished lecturer with publications including presentations before national and international consensus and professional society meetings. He continues to be an active participant in national and international laser safety standards activities. He retired from the U.S. Public Health Service Commissioned Corps with 29 years of combined uniformed service at grade of Captain, O-6.

Mr. Handren now works regularly as a regulatory consultant, 510(k) drafter, electronic product report preparer, and device GMP/QSR expert for FDAImports.

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