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Innovative Solutions for Medical Device Compliance and Success

Medical Device Expert Consultants

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Our Expert Consultants

Medical Device Experts

At xFDA, our consultants are former FDA medical device experts, engineers, and regulatory specialists with extensive experience in device development and approvals. With backgrounds in clinical engineering, device evaluation, and regulatory affairs, our team provides invaluable insights to guide clients through the complexities of medical device submissions and compliance.

Meet Our Medical Device Experts

At xFDA, our Medical Device Experts bring deep, FDA-specific regulatory expertise to the table. With experience spanning multiple device types and clinical evaluations, we offer insights and guidance that empower your business to navigate the complex regulatory landscape and achieve market approval.

Medical Devices

FDA Experience: Senior Reviewer, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH)

Expertise: Cardiac Devices, Mechanical Testing, Software Development, Electrical Testing

This expert brings over years of experience at the FDA, having worked extensively in the review of 510k, PMA, and IDE applications. Specializing in cardiac medical devices, his expertise in electrical and mechanical testing, as well as software development, helped ensure that devices met FDA standards for safety and efficacy. He now provides expert consulting services in device regulatory affairs, focusing on design validation and testing protocols for a variety of medical devices.

Key Contributions:

  • Extensive experience in 510k, PMA, and IDE application reviews

  • Specialized in cardiac and software development testing

  • Expert witness testimony on medical device compliance and regulatory matters

Medical Device Expert

FDA Experience: Expert in Radiologic Devices, Center for Devices and Radiological Health (CDRH)

Expertise: Radiology, Radiation Oncology, Medical Devices

This expert is a physicist and chemist, has significant experience evaluating radiologic devices and radiation oncology products while at the FDA. With a deep understanding of the regulatory approval process from bench-top testing to clinical evaluations, Dr. offers valuable insights into the unique challenges associated with medical devices used in radiology and oncology. His extensive experience includes managing teams of engineers and scientists to evaluate devices for market approval.

Key Contributions:

  • Led teams in device evaluations, including in-vitro diagnostics and radiation oncology

  • Expertise in FDA approval processes for medical devices

  • In-depth knowledge of clinical evaluation and market readiness

Medical Device Expert, MD

FDA Experience: Senior Medical Officer, Center for Devices and Radiological Health (CDRH)

Expertise: Clinical Regulatory Science, Device Applications, Quality Systems

With over 25 years of experience at the FDA, Dr. is an expert in the regulatory review of clinical laboratory devices. His work spanned multiple applications, including 510k, IDE, and PMA evaluations. Having managed clinical regulatory applications and good manufacturing practices (GMP) for medical devices, he is now focused on guiding companies through FDA approval and regulatory compliance for device submissions.

Key Contributions:

  • Extensive experience in 510k, IDE, and PMA evaluations

  • Expertise in clinical regulatory science and lab devices

  • Focus on good manufacturing practices (GMP) and quality system applications

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Why Our Device Experts

xFDA’s Medical Device Experts bring deep regulatory and clinical experience to help you navigate the complexities of medical device approvals. With backgrounds as former FDA regulators and industry leaders, they provide the critical insights needed to ensure compliance and successful market entry.

What Sets Our Experts Apart:

  • Former FDA Device Reviewers: Hands-on experience with 510k, PMA, and IDE submissions

  • Specialized Knowledge: Expertise in cardiac, neurology, orthopedics, and in-vitro diagnostic devices

  • Proven Track Record: Success in clinical trials, device evaluations, and market approvals

Don’t Wait to Get Started

Work with Our Device Experts

Our consultants bring unparalleled expertise to your medical device regulatory challenges. Whether you need assistance with FDA submissions, compliance strategies, or expert advice, xFDA is here to help.

Need expert guidance for your medical device project? Contact us today to discuss how our device experts can support your needs.