Convergence of Compliance and Technology

How Technology Has Changed Regulatory Compliance in the Past Decade

By Matthew M. Lowe

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About the Book

Life science companies face enormous scientific, economic, and regulatory challenges during development of medical products. While the growth of R&D has always been intertwined with technological advances, it has not been the case for regulatory compliance. The situation changed with the advent of 21 CFR Part 11, the watershed regulation that established the criteria for the use of electronic records and electronic signatures by organizations under the jurisdiction of the U.S. Food and Drug Administration.

Since 2000, we have benefited from a technology-driven era in regulatory compliance. The book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

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Matt Lowe – author of Convergence of Compliance and Technology

About the Author

Matthew M. Lowe, executive vice president at MasterControl, is a mechanical engineer with over 15 years of medical device experience in product development, product management, and regulatory compliance.

Prior to joining MasterControl in 2006, he worked in product development and product management at Ortho Development Corp. and Bard Access Systems. He has successfully launched more than a dozen medical devices and has four patents issued. His regulatory compliance experience includes writing a 510(k) that was cleared by the FDA and managing a multisite, multiyear post-market clinical study for orthopedic devices. He received a bachelor's degree in mechanical engineering from University of Utah and an MBA from Indiana University.

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