Expert Details
Medical Device Design Control and Software Validation
ID: 729752
New Jersey, USA
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
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 |
|---|---|---|---|
| Years: 2008 to Present | Employer: Undisclosed | Title: Consultant | Department: |
Responsibilities:He consults on regulatory issues with medical device companies. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| Years: 1995 to 1996 | Employer: MDI Consultants | Title: Associate Consultant | Department: |
Responsibilities:Expert consulted with medical device companies on regulatory issues. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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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
biomedical device design review, biomedical device manufacturing, Current Good Manufacturing Practice, electronic medical device, Food and Drug Administration compliance, FDA medical device regulation, Food and Drug Administration regulation, Good Manufacturing Practice training, ISO 9000 implementation, ISO 9000 quality system documentation, ISO 9000 series quality system standard, medical device auditing, medical device manufacturing, medical device process validation, medical product manufacturing, medical regulation, medical software quality assurance, medical device software, hemodialysis equipment, medical device evaluation, compliance testing, biomedical research and development, medical device reporting, durable medical equipment, medical device manufacture clean room, medical device premarket approval, medical device product development, disposable medical device, biomedical product development, medical device irradiation sterilization, medical device manufacturing automation, medical device reliability testing, medical device design