Copy to clipboard 
Empirical Technologies is expanding 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 its panel of experts.
Empirical Technologies’ office in the United States will work closely with the office in Belgium, assisting to more quickly navigate regulatory processes and get devices to market quickly and efficiently.
Source: Empirical Technologies
