MANAMED® LLC Achieves ISO 13485 Certification, Reinforcing Commitment to Quality and Global Expansion

DENTON, Texas, July 2, 2025 /PRNewswire/ -- ManaMed LLC, a leading innovator in medical device solutions, proudly announces its certification to ISO 13485 by BSI®, a globally recognized standard for quality management systems in the medical device industry. This milestone affirms ManaMed's unwavering commitment to delivering safe, effective, and high-quality products to patients and healthcare providers.

The ISO 13485 certification applies to ManaMed's entire product portfolio, which includes both Class I and Class II FDA-classified devices. This achievement not only validates the company's rigorous internal processes but also positions ManaMed for future quality growth through the Medical Device Single Audit Program (MDSAP).

"This certification is more than a regulatory benchmark—it's a reflection of our company's DNA," said Trevor Theriot, President and CEO of ManaMed. "We've always believed that innovation must be matched by integrity and quality. ISO 13485 confirms that our systems are built to deliver on that promise."

The certification process, conducted by BSI, marks ManaMed's first engagement with the organization and underscores the company's dedication to continuous improvement and global compliance. The successful audit was made possible by the tireless efforts of ManaMed's Quality and Regulatory teams, whose leadership and attention to detail were instrumental in achieving this milestone.

"This accomplishment is a testament to the culture of excellence we've built at ManaMed," added Theriot. "It sets the foundation for expanding our Class II portfolio and opens the door to new international markets."

ISO 13485 is the internationally accepted standard for quality management systems specific to the medical device industry. Certification ensures that organizations meet stringent regulatory requirements and consistently deliver products that meet customer and applicable regulatory standards.

With this certification, ManaMed is well-positioned to pursue MDSAP certification, which will enable the company to streamline regulatory compliance across multiple jurisdictions, including Canada, Australia, Brazil, and Japan.

About ManaMed
ManaMed is dedicated to providing innovative recovery solutions that empower clinicians and patients alike. ManaMed is a global leader that designs, develops, and distributes orthopedic solutions that keep active, high-performing people in the game and back-on-track following injury or surgery.

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SOURCE ManaMed LLC