SYNDEO Medical Announces ISO 13485 Certification, Expanding Regulatory Portfolio and Supporting Global Growth Strategy

/EIN News/ -- ZAVENTEM, Belgium, May 20, 2025 (GLOBE NEWSWIRE) -- SYNDEO Medical, a Belgian-based developer of interventional procedure solutions, is pleased to announce that it has received ISO 13485 certification for its quality management system. This internationally recognised certification adds to SYNDEO Medical’s growing portfolio of regulatory approvals and reinforces its continued commitment to quality, compliance, and long-term global growth.

The ISO 13485 certification builds on existing MDR approvals for the SYNDEOPack Interventional Procedure Pack™ and the Xssential Rapid Delivery Procedure Pack™, enabling the company to access new clinical markets where ISO 13485 is a regulatory requirement.

“Achieving ISO 13485 is an important milestone that reflects the systems and discipline we’ve built into our operations,” said A. Justin Lampropoulos, Founder and Chief Executive Officer of SYNDEO Medical. “From the beginning, we’ve focused on building something enduring — genuinely grounded in quality, responsiveness, and real-world clinical value.”

SYNDEO Medical is highly differentiated in the marketplace by integrating everyday-use diagnostic and interventional products—typically procured separately—into custom-designed interventional procedure packs. This approach simplifies procurement, enhances procedural efficiency, and ensures a more streamlined clinical workflow.

“As we grow, our focus remains on customer-driven innovations that deliver on our brand promise of elevating patient experience, delivering value, and empowering outcomes,” Lampropoulos added. “ISO 13485 gives us additional confidence as we continue to expand our offering and support our partners in new and existing markets.”

About SYNDEO Medical

SYNDEO Medical is engaged in the design, development, and distribution of fully integrated custom procedural solution products. Launched in 2023 by A. Justin Lampropoulos and Andrew Cotton and headquartered in Belgium, SYNDEO Medical is dedicated to pushing the boundaries of healthcare innovation. Specialising in minimally invasive interventional and surgical products, SYNDEO Medical serves healthcare providers worldwide through a network of distribution partners and sales representatives. The company is committed to positively impacting lives through elevating patient experience, delivering meaningful value, and empowering outcomes.

SYNDEO Medical Public Relations
Email: trixie@syndeomedical.com
www.syndeomedical.com

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