Expert Witness Services for Medical Device Quality Litigation

Medical Device Expertise • Clear Outcomes

Meet The Medical Device Litigation Experts

Qualified. Credible. Litigation-Ready Tesimony. Engaged in every detail of your case.

At Capwell Consulting Group, our medical device litigation expertise is led by a dedicated professional with decades of real-world experience in regulated manufacturing environments, global compliance frameworks, and quality standards.

Our lead medical device expert, Denise Holliday, brings extensive expertise in quality management systems (ISO 13485), medical device risk management (ISO 14971), and international regulatory requirements (US, EU, Canada, Brazil, Japan, etc.), and medical device risk management.

The Capwell Consulting Group Litigation-Focused Medical Device Expert Process

Structured. Responsive. Built for defense and plaintiff alike.

When your case involves a dispute over medical device manufacturing, regulatory compliance, design defects, or post-market surveillance, you need an expert who bridges medical-device science with litigation support. At Capwell Consulting Group, our expertise delivers deep technical insight, clear expert reports, and courtroom-ready testimony for your case.

Initial Case Review

Review and understand the basic facts of your case

Identify any potential conflict of opinion or interest

Case Evaluation

Review all relevant materials and evidence related to the case

Conduct any research, analysis or testing required to support the case

Formulate An Opinion

Utilize our expertise to interpret evidence and form an objective opinion

Ensure our conclusions are supported by reliable data and methodologies

Prepare A Report

Write a detailed report to explain our findings, methodologies, and conclusions

Ensure reports are clear, concise and comprehensible to non-experts

Assist with Legal Strategy

Collaborate with the legal team to develop a case strategy

Advise on the strengths and weaknesses of the case from a technical perspective

Testify in Court Proceedings

Provide testimony under oath during depositions, hearings, and trials

Explain our findings and opinions clearly and accurately
Answer questions from the defense, prosecution, and the judge

Educate the Court

Clarify technical aspects, procedures and evidence of a specific subject matter
Help the judge and jury understand the implications of the expert’s findings

Remain Impartial

Maintain objectivity and avoid any bias in our analysis and testimony

Ensure our testimony is based solely on our expertise and evidence

Maintain Knowledge and Credibility

Continuously improve our knowledge to provide accurate and reliable testimony

Avoid actions that might compromise our credibility or objectivity

Why a Medical Device Expert Witness Matters

Precise science. Credible testimony. Stronger outcomes in medical device disputes.

In medical device litigation, the distinction between liability and defense often hinges on expertise that clearly links device design, manufacturing defects, regulatory omissions, or risk management failures to patient harm. That’s where a medical device quality expert from Capwell Consulting Group becomes indispensable.

Our expert assists attorneys, manufacturers, and claimants in navigating the complexities of device regulations, and medical device manufacturing quality standards. We evaluate whether a medical device met or fell short of standards such as ISO 13485 and ISO 14971, or regulatory requirements such as those required by the US FDA, Health Canada, Japan's PMDA or other applicable markets; whether failure modes were identified, mitigated, and documented; and whether adverse event data, recalls, or design changes were documented and managed properly. With this insight, our expertise can clarify the pivotal technical issues and deliver comprehensive findings that withstand scrutiny—providing the clarity and credibility your case demands.

Contact Capwell Consulting

412-262-9191

inquiry@capwellconsulting.com

capwellconsulting.com