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 Expert  714180

Expert in Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc.

Available for your Consulting and Expert Witness Needs

Maryland (MD)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.

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.

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.

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.


medical computer system


medical device premarket approval


software product assessment


software validation




software engineering process standard


software quality assurance


software standard


medical software


medical software quality assurance


medical device software

Show Secondary and Basic Areas of Expertise
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.

Year   Degree   Subject   Institution   Honors
1998   MBA   International Business   Johns Hopkins University  
1994   MS   International Business   Johns Hopkins University  
1980   BS   Communication & Training   Towson State University   Summa Cum Laude

Work History:
Years   Employer   Department   Title   Responsibilities

1992 to







Senior Consultant

1986 to 1992


Becton Dickinson


Diagnostic Instrument Systems


Manager of Software Quality Assurance


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

1984 to 1986


General Instrument Corp.



Software Quality Associate


Software Quality Testing and Documentation

Career Accomplishments:




Professional Appointments

Executive Board of AAMI Software Committee; Secretary of AAMI Software Committee

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.

Selected Publications and Publishers  
 - Marcel Dekker  
 - Software Quality Mgmt, Inc.  

Government Experience:
Years   Agency   Role   Description
1994 to 1994   FDA   Training   Trained the Office of Science and Technology on International and Domestic Software Standards
1997 to   FDA   Committee Participation   Jointly participated on ISO/IEC committee on Software Engineering / Software Integrity
1998 to   FDA   Committee Participation   Jointly participated on AAMI software sub-subcommittee

Consulting Services:
Selected Consulting Examples:
  • Expert witness for medical device product liability suit
  • Compliance turn-around after issuance of FDA Warning Letter including retrospective product and process documentation
  • FDA PMA for cutting-edge medical device
  • 510(k) for medical devices
  • Validation and Verification for software products and automated manufacturing processes
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:
Expert Witness Experience Summary:
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.
Recent Litigation Client Requests:
  • Expert witness on pacs for consulting on PACS.
  • Pacs computer system expert witness for consulting on Medical Malpractice case with PACS records at issue.
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
1986 to 1992   Europe and Japan   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.
to   20 countries worldwide   She was the editor of a newsletter called the 'Global Interface' containing software quality and product information that was distributed to 20 countries worldwide
1990 to   32 countries worldwide   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.
1986 to 1992   USA, Europe, Asia Pacific   She was the corporate resource on Software Quality Management and as such, trained all corporate divisions on this subject.

Market Research:
She has assisted many times in assisting with bringing new products through the FDA process and into commercialization.

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:

She has delivered many training sessions on FDA and Software Regulations.


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