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Monday, June 5, 2023

MEDICAL DEVICE NEWS MAGAZINE

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Empirical Technologies Expands Location and Services

Empirical Technologies expands its locations and services with the launch of Empirical Europe, headquartered in Belgium. Johan Van Havermaet and Xavier Deklerck are leading the company’s European presence. Van Havermaet brings a strong background in spine and emerging technologies to the team. Deklerck has built a career in foot, ankle, and trauma products. Empirical Technologies Founder Dawn Lissy said the expansion of the company she founded has been a long-term goal.

“For years, we’ve looked to Europe as a strong and natural extension of our global footprint,” she said. “For 24 years, we’ve worked to meet the needs of clients around the world. Adding Johan and Xavier to the team means we now have the right professionals in place to better serve a critical segment of the market and our industry in the European Union.” In addition to mechanical testing and Medical Device Directive to Medical Device Regulation support, the Empirical Europe team will provide regulatory support for future MDR and FDA submissions.

The Empirical Technologies engineering team has over 50 years of combined testing experience, participates actively in several ASTM committees, and has hosted FDA reviewers for Experiential Learning Program events. Empirical Technologies’ consulting experts have a proven record of regulatory success with three Breakthrough Device Designations, more than 250 FDA 510(k) clearances, and has recently added a former director of multiple FDA divisions to our panel of experts. To continue providing our clients with top-of-the-line service, our office in the United States will work closely with our office in Belgium.

The Empirical Technologies and Empirical Europe teams are ready to assist clients with their testing and regulatory needs around so they can more quickly navigate regulatory process and get devices to market quickly and efficiently. For more information, visit EmpiricalEurope.com.

 

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Medical Device News Magazine, (division of PTM Healthcare Marketing, Inc., is a digital publication reporting the latest medical device, clinical trials, product launches, funding, mergers/acquisitions and biotech/diagnostic industry news.

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