Sally Bowden
The P3 Acceleration Group
289 S Peru Street
Cicero, IN 46034
Cicero, IN 46034
Mobile: 317-727-6761
Office: 317-727-6761
Office: 317-727-6761
Introduction
Sally Bowden is an experienced medical device and diagnostic compliance professional. She has over 25 years of experience in due diligence, auditing, design control, clinical affairs, reimbursement, regulatory affairs, ISO 13485, risk management, manufacturing and distribution. Her background is in engineering with a strong focus on FDA compliance requirements in this space. She has co-founded multiple companies with IP spinning out from well-known academic medical institutions.
Areas of Expertise
- Analytical Testing Labs
- HIPAA
- Medical Devices
Expert Background
- Q: Please list your professional accreditations, degrees, licenses, and certificates granted:
- A: Member of Indiana Health Industry Forum, Regulatory Affairs Professionals
Bachelor of Science in Engineering
Master of Business Administration
Certified Six Sigma Master Black Belt
- Q: Please list any teaching or speaking experience you have had, including subject matter:
- A: I was an engineering professor for Purdue University from 2000-2004
I speak and teach frequently for clients through my consulting firm
Speaking on a panel regarding the Future Of MedTech, hosted by BioBridges regarding the changing regulatory environment and the impact on life science, device and pharmaceutical companies.
I have also spoken on the application of Baldridge criteria in higher education.
I developed curriculum as a national improvement advisor for the Veteran's Health Administration. - Q: Have any of your accreditations ever been investigated, suspended or removed? (if yes, explain)
- A: No.
- Q: On how many occasions have you been retained as an expert?
- A: 4
- Q: For what area(s) of expertise have you been retained as an expert?
- A: Regulatory affairs, ISO 13485, FDA, QSR, ISO 14971, medical device, diagnostics, total quality management, quality engineering
- Q: In what percentage of your cases were you retained by the plaintiff?
- A: 100%
- Q: On how many occasions have you had your deposition taken?
- A: 3
- Q: When was the last time you had your deposition taken?
- A: 2/2026
- Q: On how many occasions have you been qualified by a court to give expert testimony?
- A: 1
- Q: On how many occasions have you testified as an expert in court or before an arbitrator?
- A: 1
- Q: For how many years have you worked with the legal industry as an expert?
- A: I consult with legal teams now through my consulting firm and have for the past 10 years.
- Q: What services do you offer? (E.g.: consulting, testing, reports, site inspections etc.)
- A: Consulting, auditing, due diligence, document review, data review, gap analysis, site inspections, discovery review, root cause analysis.
- Q: What is your hourly rate to consult with an attorney?
- A: $325
- Q: What is your hourly rate to review documents?
- A: $325
- Q: What is your hourly rate to provide deposition testimony?
- A: $400. Minimum of 3 hours
- Q: What is your hourly rate to provide testimony at trial?
- A: $500. Minimum of 4 hours.
- Q: Please list any fees other than those stated above (E.g.: travel expenses, copy fees, etc.)
- A: Travel expenses and administrative costs if applicable. Travel days billed at $325/hour plus expenses
References
Available Upon Request