Expert Details

Software - Quality Assurance, Regulatory Affairs and Licensing

ID: 730387 United Kingdom

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Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA and beyond, accreditation and certification to ISO standards, vendor/software selection, validation etc.

Education

Year Degree Subject Institution
Year: 1982 Degree: NDip (BSc equivalent) Subject: Automation and Instrumentation Institution: Halton Technical Institute

Work History

Years Employer Title Department
Years: 2008 to 2011 Employer: Swiss Precision Diagnostics Title: Software Quality Assurance Department:
Responsibilities:
Responsible for SQA for product and manufacturing/consumer care and other supporting software

Fields of Expertise

embedded software, ISO 9000 implementation for software, ISO/IEC 12207 -- Software Life Cycle Processes standard, medical device software, medical software, medical software quality assurance, software certification, software documentation control, software life cycle, software quality assurance, software registration process, software validation, embedded software testing, embedded system software development, document management software, enterprise resource planning software, computer software technology innovation, CASE tool, application software, computer programming

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