Two of the most prominent medical regulatory consultants in Northeast Ohio now are working for the same company.
Matrix Medical Devices of Cleveland has acquired Mentor-based REU Associates — a deal that reunites former colleagues Stephanie Harrington and Ray Ursick.
Ursick is REU’s only employee, but he typically works with seven to 10 contractors at any given time, he said.
Now he and his network are working on behalf of Matrix Medical Devices, which Harrington founded in mid-2013. Six employees are listed on Matrix’s website.
Both companies help medical device makers comply with domestic and international regulations. However, they each have their own specialties.
For instance, Ursick has more experience helping companies fix problems spotted by regulators. He also has helped medical device makers get through the U.S. Food & Drug Administration’s premarket approval process. Companies have to go through the stringent process before they can start selling riskier “Class III” devices — devices that could hurt someone if they fail.
On the flip side, Matrix Medical Devices has more engineering expertise. The company often helps medical device makers design new products so that they meet FDA standards.
“There’s more of an … expertise in design development in her firm than in mine,” Ursick said.
Ursick and Harrington have known each other for nearly 20 years. They met while working for Steris Corp., a medical equipment company in Mentor.
They’ve kept in touch since then and sometimes worked together on regulatory consulting projects, Ursick said.
The partnership is already helping Matrix Medical Devices win new business, Harrington said via email.
“We are already seeing the positive results,” she said
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