MARQUETTE, MI, UNITED STATES, March 2, 2026 /EINPresswire.com/ — EXALTA Group (EXALTA) today announced a major milestone achieving EU-MDR certification to support a broader set of fixation applications using plates and cables, helping customers advance European growth with confidence.
The United States remains a core focus for many EXALTA programs, and Europe continues to be a priority region as customers expand distribution and broaden patient access. As EU-MDR expectations increase around traceability, lifecycle oversight, and system performance, EXALTA has reinforced the quality foundation that helps customers keep programs moving and reduce friction between development, manufacturing, and regulatory requirements.
“Customers choose EXALTA because they need progress, not handoffs,” said Ross Sylvia, Chief Commercial Officer for integrated OEM Solutions at EXALTA. “This milestone strengthens our ability to help medical device companies expand faster and scale beyond the U.S. without losing momentum.”
The certified scope includes device groups such as bone fixation plates and bone fixation cables, intended for temporary fixation and/or stabilization of skeletally mature bone in orthopedic trauma and reconstructive surgery. Depending on device type and configuration, these technologies may be used in applications such as:
• Securing fractures of the olecranon, patella, femur, and humerus
• Reattaching the greater trochanter during total hip arthroplasty
• Greater tuberosity humerus fractures
• Fixation and/or stabilization of long bones
EU-MDR submissions are complex and resource intensive. This milestone reflects EXALTA’s full-service support across the product lifecycle, helping customers accelerate speed-to-market through regulatory readiness and scalable execution.
EXALTA is exhibiting this week at American Academy of Orthopaedic Surgeons (AAOS). Visit EXALTA at Booth 1619 to connect with the team and discuss how EXALTA helps OEM teams accelerate speed-to-market through regulatory readiness and scalable execution across geographies.
About EXALTA Group
With operations across multiple continents, EXALTA Group is a global solutions provider for the MedTech industry. Through its Manufacturing Solutions and Integrated OEM Solutions business units, the company supports leading OEMs in delivering breakthrough medical devices that improve patient outcomes worldwide.
EXALTA is an integrated MedTech partner supporting customers from development through scalable manufacturing. The group supports leading OEMs in delivering breakthrough medical devices that improve patient outcomes worldwide by bringing complex programs to market faster and scale.
Learn more at exalta.com
Francois Samson
EXALTA Group
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