Anaheim Convention Center | Anaheim, CA | July 26–30, 2026
LAS VEGAS, July 15, 2026 /PRNewswire/ -- CovarsaDx®, a contract research organization focused exclusively on in vitro diagnostics (IVD) and diagnostic medical devices, will exhibit at the Association for Diagnostics & Laboratory Medicine (ADLM) Annual Scientific Meeting & Clinical Lab Expo, taking place July 26–30 at the Anaheim Convention Center in Anaheim, California. Senior members of the CovarsaDx team will be on-site at Booth #1477, with meeting slots available now for attendees who want dedicated time with the team.
At the booth, the CovarsaDx team will walk attendees through its end-to-end approach to IVD and diagnostic clinical research — from regulatory strategy and study design through site management, enrollment, data management, and submission-ready reporting. Attendees can expect focused conversations on regulatory pathway planning, protocol development aligned with submission requirements, and evidence strategies built for 510(k), De Novo, and PMA programs.
The team will also be available to discuss SitePath™, CovarsaDx's dedicated site operations function, and TrialPathDx™, its proprietary Clinical Trial Management System — two capabilities that support proactive study and site management.
As part of its continued investment in the expertise sponsors depend on, CovarsaDx recently welcomed Lisa Baumhardt as Senior Director, Regulatory Affairs, who will also be onsite at ADLM.
Lisa brings more than 30 years of experience across medical devices, IVDs, digital health, and combination products, with a track record spanning regulatory strategy and submissions, including 510(k), De Novo, and PMA. Lisa previously worked with Hyman, Phelps & McNamara, one of the country's leading FDA law firms, as well as GE Healthcare, IBM Watson Health, Beckman Coulter, and Abbott Laboratories. She holds an MS in Healthcare Technology Management, a Master of Jurisprudence in Health Law from Loyola University, and is a Fellow of the Regulatory Affairs Professional Society (FRAP). She has also been invited by the FDA to speak at public workshops on artificial intelligence in medical devices.
Lisa's addition deepens CovarsaDx's regulatory expertise across the full study lifecycle, from pathway assessment and pre-submission strategy through clinical execution and regulatory submission.
"Lisa's background is exactly what our sponsors need in a regulatory partner," said Chermaen Lindberg, President and CEO of CovarsaDx. "Her depth across IVDs, medical devices, and FDA submissions, combined with her experience on both the industry and legal side, brings a level of regulatory judgment to our team that directly benefits every sponsor we work with."
That regulatory strength is built into how CovarsaDx operates from the start of every engagement.
"Successful regulatory submissions require more than just good study execution," said Mark Boyle, Chief Operations Officer of CovarsaDx. "Clinical, regulatory, and quality strategies must work together from the beginning. We partner closely with sponsors to make the right decisions early and execute studies designed to hold up under regulatory review."
Meeting slots fill quickly in the weeks before ADLM. Reach out now to secure dedicated time with the team.
Schedule a meeting by reaching to [email protected]. Walk-ins are also welcome at Booth #1477.
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 evolving regulatory requirements to enable faster pathways to market. Our team brings extensive industry experience across regulatory, quality, and clinical operations, including regulatory strategists, quality specialists, study managers, monitors, data managers, and statisticians, working in sync to generate the robust evidence needed to advance life-saving technologies.
Media: [email protected]
SOURCE CovarsaDx
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