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Bob is a co-founder of the company and oversees
technical services as Vice-President, Quality Assurance, Regulatory Affairs,
and Design Control Services. His experience includes:
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35 years medical device industry experience in
diagnostic and therapeutic products
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Experience and expertise includes:
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Engineering (HW/SW), QA/RA, design control,
management
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Requirements, risk analysis, V&V, design
transfer
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Designed & implemented a design control system that
was highly rated during a design control audit by an FDA reviewer
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Wrote SW Requirements Spec. for client whose 510(k)
was rejected for lack of SRS—510(k) was subsequently approved
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