Expert Details

Expert in Medical Device Design Control and Software Validation

Expert ID: 729752 New Jersey, USA

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Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design and manufacturing including selection and qualification of vendors. Specific areas of expertise include design control, risk analysis, product (including software) and process validation and documentation systems. He is very experienced in conducting audits to identify problem areas and leading corrective action teams.

Expert travels internationally to help clients and has recently been to Great Britain and Canada helping an IVD development company and an in home hemodialysis system development company.

He helped a British company obtain a 510(k) for a software controlled device to measure blood flowHe provided a review of a program to develop a home dialysis systemHe helped a heart laser company with their design control and validation program

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Trenton, New Jersey - Philadelphia, Pennsylvania - Allentown, Pennsylvania - Baltimore, Maryland

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Education

Year Degree Subject Institution
Year: 1985 Degree: MBA Subject: Finance and Marketing Institution: Drexel University
Year: 1962 Degree: BS Subject: Mechanical Engineering Institution: Polytechnic Institute of New York University

Work History

Years Employer Title Department Responsibilities
Years: 2008 to Present Employer: Undisclosed Title: Consultant Department: Responsibilities: He consults on regulatory issues with medical device companies.
Years: 2002 to 2008 Employer: Chrysalis Technologies Title: Project Leader Department: Responsibilities: He developed the design control program for this startup company developing devices to deliver medicine by inhalation.
Years: 1996 to 2002 Employer: Controls Corporation of America Title: Director of Enginering Department: Responsibilities: He was responsible for product design and manufacturing for this ISO 9000 certified manufacturer of flow control components for medical and industrial applications.
Years: 1995 to 1996 Employer: MDI Consultants Title: Associate Consultant Department: Responsibilities: Expert consulted with medical device companies on regulatory issues.
Years: 1992 to 1995 Employer: National Medical Care Title: Manager Dialysis Equipment Group Department: Responsibilities: He was responsible for engineering, manufacturing, regulatory and quality, and field service for this manufacturer of kidney dialysis systems.
Years: 1988 to 1992 Employer: ARDE, Inc. Title: Project Engineer Department: Responsibilities: He was responsible for development of automated systems to control breathing air and the fire suppression system for the NASA International Space Station.

International Experience

Years Country / Region Summary
Years: 2009 to 2009 Country / Region: Great Britian Summary: He helped this company obtain a 510(k)
Years: 2010 to 2010 Country / Region: Canada Summary: He provided a review of the development program for an in home hemodialysis system

Fields of Expertise

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