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, Ekman 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.

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.

Additional information

Alan Donze, CEO, tel. +1 619 977 5285

About Bioretec

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of absorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries. 

Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable of around USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better Healing - Better Life. www.bioretec.com