Expert Details

Expert in Software - Quality Assurance, Regulatory Affairs and Licensing

Expert 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 Responsibilities
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

Government Experience

Years Agency Role Description
Years: 2011 to Present Agency: Enterprise Ireland Role: Regulatory Strategist Description: Developed Regulatory strategy for a number of 'Spin-out' companies

International Experience

Years Country / Region Summary
Years: to Present Country / Region: USA and Puerto Rico Summary: Software Quality Assurance for clients throughout USA and Puerto Rico
Years: to Present Country / Region: Mainland Europe Summary: Software Quality Assurance for clients throughout Europe
Years: to Present Country / Region: Ireland Summary: Software Quality Assurance for clients throughout Ireland
Years: 1999 to 2000 Country / Region: Singapore Summary: Software Quality Assurance for clients throughout Singapore

Additional Experience

Vendor Selection
PDA Software Vendor Auditor 1999;
Have audited over 40 potential or actual vendors of software for clients
Marketing Experience
Have gained licenses for a number of medical devices that contain software.
Have hosted or been on call for a number of audits that clients have been subjected to from regulatory authorities.
Have been party to the removal of consent decree for clients.

Fields of Expertise

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