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Expert in Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc.
Available for your Consulting and Expert Witness Needs
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| Summary of Expertise: |
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Primary Expertise Areas:
(links show more experts in each area)
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Expertise Description: |
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medical computer system expert
medical device premarket approval expert |
A nationally recognized expert in these areas, Expert has been dedicated to this field since 1986, when the FDA wrote their initial software guidance document. She has been responsible for compliance turn-around and start-up companies initial submissions or Fortune 100 companies compliance needs. She is able to supply ready-to-use Standard Operating Procedures for Instant Software Compliance, Instant Design Control Compliance, and Instant Risk Management, as well as software documentation and submission templates. A recognized speaker known by software-related personnel at the FDA, Expert has provided training in this subject. She is the publisher of the only newsletter dedicated to medical software, Medical Software Weekly. Expert has also implemented infrastructures for various healthcare companies to validate and verify computer systems. She audited existing documentation for adequacy and performed pre-acquisition software regulatory risk assessments. She has assisted with the software implementation. |
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software product assessment expert
software validation expert
telemedicine expert |
Having worked in these areas since 1984, Expert is experienced with protocol development, protocol execution, results analysis, and summary reports. She is also familiar with reviewing protocols and results for acceptability. Additionally, she is experienced with testing products, automated manufacturing processes, and off-the-shelf software. Other areas of Expert's expertise include software verification (including module testing), integration testing, reviews, inspections, analysis, and walkthroughs. She has conducted various tests including stress, boundary, branch, and path tests. Expert is also familiar with testing communication protocols such as DICOM and HL7. Lastly, Expert has knowledge of telemedicine configuration testing and PACS devices. |
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software engineering process standard expert
software quality assurance expert
software standard expert |
Expert provides assessment of business and software processes to determine interrelationship and provides plan of action to better integrate the two through measurement and improved strategic planning. |
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medical software expert
medical software quality assurance expert |
Expert was employed as a Software Quality Assurance Associate for General Instruments in the mid-1980s. Since then, she has been fully employed and focused in the field of medical software, implementing compliant infrastructures and performing audits, including pre-acquisition software quality risk assessments. |
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medical device software expert |
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| Show Secondary and Basic Areas of Expertise |
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Philadelphia, Pennsylvania; Allentown, Pennsylvania; Reading, Pennsylvania; Lancaster, Pennsylvania; Baltimore, Maryland; Frederick, Maryland; Camden, New Jersey; Vineland, New Jersey; Wilmington, Delaware; and Alexandria, Virginia.
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| Year |
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Degree |
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Subject |
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Institution |
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Honors |
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1998
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MBA
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International Business
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Johns Hopkins University
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1994
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MS
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International Business
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Johns Hopkins University
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1980
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BS
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Communication & Training
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Towson State University
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Summa Cum Laude
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1992 to
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(Undisclosed)
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President
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Senior Consultant
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1986 to 1992
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Becton Dickinson
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Diagnostic Instrument Systems
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Manager of Software Quality Assurance
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Responsible for all software related products within division; Corporate resource on the subject of Software Quality Assurance; Established worldwide and corporate procedures for Software Quality; Editor of Corporate-wide newsletter on the subject of Software Quality Assurance
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1984 to 1986
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General Instrument Corp.
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Software Quality Associate
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Software Quality Testing and Documentation
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Associations/Societies
ASQ, RAPS, IEEE, ACM, AAMI, ISO/IEC/JTC1/SC7, AABB
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Licenses/Certifications
CQA, CSQE
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Professional Appointments
Executive Board of AAMI Software Committee; Secretary of AAMI Software Committee
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| Publications: |
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Publications and Patents Summary
She has written one chapter on 'Software Standards' in the 'Handbook of Medical Device Design' & one chapter on 'Healthcare Systems' in the 'Encyclopedia of Software Engineering'; Publisher of 'Medical Software Weekly' Newsletter; One patent-pending.
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Selected Publications and Publishers
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- Marcel Dekker
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- Software Quality Mgmt, Inc.
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| Government Experience: |
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| Years |
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Agency |
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Role |
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Description |
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1994 to 1994
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FDA
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Training
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Trained the Office of Science and Technology on International and Domestic Software Standards
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1997 to
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FDA
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Committee Participation
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Jointly participated on ISO/IEC committee on Software Engineering / Software Integrity
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1998 to
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FDA
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Committee Participation
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Jointly participated on AAMI software sub-subcommittee
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| Selected Consulting Examples: |
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Expert witness for medical device product liability suit
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Compliance turn-around after issuance of FDA Warning Letter including retrospective product and process documentation
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FDA PMA for cutting-edge medical device
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510(k) for medical devices
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Validation and Verification for software products and automated manufacturing processes
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As a member of the Intota consultant network,
Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Telemedicine Configuration Testing Consultant and PACS Devices Consultant, Software QA Consultant, FDA Warning Letters Consultant, etc. Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company,
or consulting firm. Consultants service will be covered by a consulting contract.
Ask an expert initial screening questions and ask the experts services particulars, by simply submitting
an expert request.
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Expert Witness Experience Summary:
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She has been an expert witness for a medical device product liability lawsuit. Through extensive investigation, she determined the root cause of the problem and the associated liabilities.
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Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support,
forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright),
product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation,
and forensic testing if appropriate in litigation areas as a Telemedicine Configuration Testing Expert Witness and PACS Devices Expert Witness, Software QA Expert Witness, FDA Warning Letters Expert Witness, etc. Expert Witness.
Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and
ask the experts services particulars by submitting an expert request.
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| International Experience: |
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Country / Region |
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Summary |
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1986 to 1992
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Europe and Japan
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Established a grassroots level approach to a coordinated Software Quality Assurance approach and for Product Development between the USA, Europe, and Japan resulting in a signed procedure by region. This became the basis for a corporate approach to Software Quality Assurance and Product Development.
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to
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20 countries worldwide
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She was the editor of a newsletter called the 'Global Interface' containing software quality and product information that was distributed to 20 countries worldwide
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1990 to
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32 countries worldwide
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She participates as a USA delegate to ISO/IEC, JTC1/SC7 to develop international standards for Software Engineering. The USA is one of 32 countries that participates in this effort.
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1986 to 1992
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USA, Europe, Asia Pacific
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She was the corporate resource on Software Quality Management and as such, trained all corporate divisions on this subject.
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She has assisted many times in assisting with bringing new products through the FDA process and into commercialization.
Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc..
Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for
custom business to business (b2b) and industrial market research. Intota uses analyst and
consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative
and quantitative data as well as report writing for the custom studies. The methods and tools
used by Intota market research combine the insights of technical experts and industry insiders with secondary
research to provide the custom b2b and industrial market research you need.
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| Additional Skills and Services: |
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Training/Seminars
She has delivered many training sessions on FDA and Software Regulations.
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Expertise
