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 Expert  729752

Expert in Medical Device Design Control and Software Validation


Available for your Consulting and Expert Witness Needs

New Jersey (NJ)
USA
Education Work HistoryPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

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.

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biomedical device design review

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biomedical device manufacturing

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Current Good Manufacturing Practice

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electronic medical device

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Food and Drug Administration compliance

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FDA medical device regulation

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Food and Drug Administration regulation

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Good Manufacturing Practice training

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ISO 9000 implementation

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ISO 9000 quality system documentation

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ISO 9000 series quality system standard

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medical device auditing

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medical device manufacturing

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medical device process validation

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medical product manufacturing

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medical regulation

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medical software quality assurance


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Baltimore, Maryland.

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

Work History:
Years   Employer   Title   Responsibilities

2008 to

 

(Undisclosed Consulting Company)

 

Consultant

 

He consults on regulatory issues with medical device companies.

2002 to 2008

 

Chrysalis Technologies

 

Project Leader

 

He developed the design control program for this startup company developing devices to deliver medicine by inhalation.

1996 to 2002

 

Controls Corporation of America

 

Director of Enginering

 

He was responsible for product design and manufacturing for this ISO 9000 certified manufacturer of flow control components for medical and industrial applications.

1995 to 1996

 

MDI Consultants

 

Associate Consultant

 

Expert consulted with medical device companies on regulatory issues.

1992 to 1995

 

National Medical Care

 

Manager Dialysis Equipment Group

 

He was responsible for engineering, manufacturing, regulatory and quality, and field service for this manufacturer of kidney dialysis systems.

1988 to 1992

 

ARDE, Inc.

 

Project Engineer

 

He was responsible for development of automated systems to control breathing air and the fire suppression system for the NASA International Space Station.


Publications:
Publications and Patents Summary

He has 5 issued and 2 pending patents


Consulting Services:
Selected Consulting Examples:
  • He helped a British company obtain a 510(k) for a software controlled device to measure blood flow
  • He provided a review of a program to develop a home dialysis system
  • He helped a heart laser company with their design control and validation program
Recent Client Requests:
  • Expert for consulting on Quality Assurance Assessment.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

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

Additional Skills and Services:
Supplier and Vendor Location and Selection

He has selected and qualified 43 vendors for medical device components including plastic component molders, pharmaceutical filling, sterilizers and contract manufacturers.


 

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