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 Expert  730387

Expert in Software - Quality Assurance, Regulatory Affairs and Licensing


Available for your Consulting and Expert Witness Needs

United Kingdom
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.
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embedded software

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ISO 9000 implementation for software

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ISO/IEC 12207 -- Software Life Cycle Processes standard

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medical device software

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medical software

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medical software quality assurance

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software certification

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software documentation control

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software life cycle

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software quality assurance

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software registration process

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software validation


Show Secondary and Basic Areas of Expertise

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

Work History:
Years   Employer   Title   Responsibilities

2008 to 2011

 

Swiss Precision Diagnostics

 

Software Quality Assurance

 

Responsible for SQA for product and manufacturing/consumer care and other supporting software


Career Accomplishments:
Associations/Societies

ISPE, IEEE


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

Consulting Services:
Recent Client Requests:
  • Expert for consulting on Software Validation
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
to   USA and Puerto Rico   Software Quality Assurance for clients throughout USA and Puerto Rico
to   Mainland Europe   Software Quality Assurance for clients throughout Europe
to   Ireland   Software Quality Assurance for clients throughout Ireland
1999 to 2000   Singapore   Software Quality Assurance for clients throughout Singapore

Market Research:
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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

PDA Software Vendor Auditor 1999; Have audited over 40 potential or actual vendors of software for clients


 

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