The Blueprint for Integrating Business Processes in Medical Device Companies

by Mark Rutkiewicz BEE, MALS, PE & CMII



Book Details

Language : English
Publication Date : 6/8/2018

Format : Softcover
Dimensions : 8.5x11
Page Count : 472
ISBN : 9781480860544

About the Book

Consiliso is a concept that will help any medical device company properly design business processes.

Mark Rutkiewicz draws upon his thirty years of experience in the medical device industry to present the framework, which seeks to:

break down preconceived notions on implementing the requirements of applicable laws, regulations, guidance, standards, and internal policies;

provide blueprints for every aspect (what, why, and how) of work at your company;

promote transparent companywide information and the ability to quickly adopt changes;

achieve modular and reusable business processes and master datasets across business functions; and

move management controls to key business process metrics, instead of only financial considerations.

The author synthesizes the best practices from Configuration Management II, Information Mapping, LEAN, Six Sigma, systems engineering, and the Capability Maturity Model for integration into a process-based, flexible architecture.

Discover a new methodology for designing integrated business management processes and systems using a process approach that draws on the best practices of numerous fields with Consiliso.

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About the Author

Mark Rutkiewicz BEE, MALS, PE, CMII, is the vice president of quality at Innovize, a contract manufacturer for the medical device industry. He earned a bachelor of electrical engineering from the University of Minnesota and a master’s of applied liberal studies from Hamline University in St. Paul, Minnesota. He is a Kellogg executive scholar, Configuration Management II certified, and a certified professional engineer. His expertise in the medical device industry includes managing all areas of product development, quality, regulatory, operations, and information management activities for Class I, II, and III implantable and nonimplantable medical devices.