CovarsaDx Strengthens Regulatory Expertise with Industry Veteran David Ikeda

LOS ANGELES, Feb. 10, 2025 /PRNewswire/ -- CovarsaDx, a prominent Clinical Research Organization (CRO) well-known for its expertise in the areas of in vitro diagnostics (IVDs) and medical devices, proudly announces the addition of David Ikeda as senior regulatory affairs strategist.

Ikeda joins CovarsaDx's team of experts to enhance regulatory strategy and clinical operations for sponsors navigating the complex and evolving global regulatory landscape. With over 35 years of experience in medical devices and IVDs, Ikeda brings exceptional knowledge and leadership to the organization.

"David's extensive experience in regulatory affairs and his proven success with FDA and European Union (EU) in vitro diagnostic regulation (IVDR) submissions make him an invaluable asset to our team," said Chermaen Lindberg, president and CEO of CovarsaDx. "His knowledge and leadership will help our clients navigate the regulatory landscape, ensuring their products reach patients as quickly and efficiently as possible."

Ikeda most recently served as senior staff/principal of regulatory affairs at Beckman Coulter, Inc., where he spearheaded global regulatory functions supporting the blood virus program development team. Prior to this, he held leadership roles at ARKRAY USA and DiaSorin, Inc., and worked as an independent consultant. His extensive background spans product quality, research and development, regulatory strategy, and operational execution.

Throughout his career, Ikeda has played an instrumental role in launching products through clinical trials, registration efforts, and post-market quality processes. His achievements include bringing blood virus and infectious disease tests to worldwide markets, along with significant contributions to therapeutic areas such as bone and mineral metabolism, cancer oncology, glucose/HbA1c, and urine chemistry.

"I'm thrilled to join the team at CovarsaDx," said Ikeda. "It's clear they're dedicated to helping bring important medical innovations to market, a mission I'm truly passionate about supporting. I can't wait to dive in, share what I've learned over the years, and help our clients navigate the regulatory process successfully."

Ikeda's expertise includes FDA and EU submissions for the IVD industry, such as 510(k), premarket approval (PMA), PMA supplements, annual reports, and Class D IVDR dossiers. His proven track record of success strengthens CovarsaDx's ability to guide clients through complex regulatory pathways and deliver reliable results.

"Navigating regulatory pathways requires both deep expertise and a strategic mindset," said Marielle Lejcher, vice president of regulatory affairs at CovarsaDx. "David brings both, and his addition to our team strengthens our ability to support clients through every stage of the submission process."

About CovarsaDx
CovarsaDx is a prominent Clinical Research Organization (CRO) specializing in the areas of in vitro diagnostics (IVDs) and medical devices. The company provides agile responses to patient population needs and fluctuations in regulatory requirements for rapid market pathways. Their team of regulatory, quality, and clinical experts have extensive industry experience and consist of regulatory strategists, quality experts, study managers, monitors, data managers, and statisticians who work together to deliver reliable clinical results, enabling clients to bring life-saving technologies to market efficiently.

Media: media@covarsadx.com
Study Inquiries: studies@covarsadx.com

CovarsaDx^® is a registered trademark of CovarsaDx Corporation.

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SOURCE CovarsaDx