Bioretec Ltd, a pioneer in absorbable orthopedic implants, has appointed Mirva Ekman, M.Sc. (Mechanical Engineering), as Quality Director and member of the Management Team as of 22 April 2025.
In this role, she will oversee the company’s Quality Assurance and Quality Control functions, serve as a quality function management representative to European and U.S. regulatory authorities, and report directly to the CEO.
The decision to separate Regulatory Affairs and Quality functions aligns with Bioretec’s growth strategy, ensuring that business requirements are effectively managed while dedicating specialized resources to securing new product approvals.
As part of this transition, Mari Ruotsalainen, currently RA/QA Director, will continue as a key member of the Management Team, focusing on her role as Regulatory Affairs Director and acting as a Person Responsible for Regulatory Compliance. In her role, Ruotsalainen reports directly to the CEO.
Mirva Ekman joins Bioretec from Askel Healthcare Ltd, where she served as Chief Quality and Regulatory Affairs Officer. With over 20 years of experience in quality and regulatory leadership, she brings extensive expertise in integrating regulatory requirements into quality management systems. Her background includes working with absorbable medical devices and holding senior positions at Artic Biomaterials Oy, ConMed Linvatec Biomaterials Oy, and Perlos Corporation.
“Mirva’s extensive experience in quality and regulatory leadership, particularly in absorbable medical devices, makes her an outstanding addition to Bioretec’s Management Team. As we continue to expand, strengthening both quality and regulatory capabilities is critical. We are delighted to welcome Mirva to our team,” said Alan Donze, CEO of Bioretec.
