ManaMed LLC Achieves ISO 13485 Certification to Elevate Quality Standards in Medical Devices

ManaMed LLC Achieves ISO 13485 Certification



ManaMed LLC, a prominent innovator in the sphere of medical device solutions based in Denton, Texas, has proudly announced its recent certification to ISO 13485 by BSI®, a well-respected entity in the realm of quality management systems for the medical device industry. This significant achievement not only reinforces ManaMed's dedication to delivering safe and effective products to patients and healthcare professionals but also sets a foundation for future global expansion.

Achieving ISO 13485 certification signifies compliance with rigorous international standards, reflecting the company's unwavering commitment to maintaining premium quality across its product range. The certification encompasses ManaMed's entire portfolio, including both Class I and Class II FDA-classified devices. This milestone not only serves as a validation of ManaMed's internal processes but also provides a clear pathway for the company to pursue further advancement through the Medical Device Single Audit Program (MDSAP).

Trevor Theriot, President and CEO of ManaMed, highlighted the significance of this certification by stating, "This certification is more than a regulatory benchmark—it's a reflection of our company's DNA. 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, executed by BSI, marks ManaMed’s first significant interaction with the organization and underscores the company’s commitment to continuous improvement and adhering to global compliance standards. This successful audit was made possible through the diligent efforts of ManaMed's Quality and Regulatory teams, whose leadership was pivotal in attaining this accomplishment. Theriot remarked, "This accomplishment is a testament to the culture of excellence we've built at ManaMed. It sets the foundation for expanding our Class II portfolio and opens the door to new international markets."

ISO 13485 is recognized worldwide as the standard for quality management systems in the medical device industry. Being certified means that ManaMed is equipped to meet stringent regulatory requirements while consistently delivering products that satisfy both customer and applicable regulatory standards. This certification will further enable ManaMed to seek MDSAP certification, streamlining the regulatory compliance process across multiple jurisdictions including Canada, Australia, Brazil, and Japan.

With this new certification, ManaMed is positioning itself to enhance efficiency and effectiveness in compliance processes while pursuing new global market opportunities. The commitment to quality doesn’t merely serve as a significant milestone — it’s a strategic step towards ensuring the long-term success and growth of ManaMed as it continues to innovate in orthopedic solutions designed to help patients regain mobility and enhance their quality of life.

Founded with a mission to provide innovative recovery solutions, ManaMed is a global leader dedicated to designing, developing, and distributing orthopedic products that empower both clinicians and patients. With a clear vision and commitment to quality, ManaMed is poised to lead in the medical device industry while ensuring that those who rely on its products can trust in their efficacy and safety. As they celebrate this achievement, ManaMed remains focused on their core principles of integrity, innovation, and dedication to healthcare excellence.

For continued updates on ManaMed's innovations and expansion efforts in the orthopedic space, keep an eye on their press releases and company announcements as they embark on this exciting new chapter.

Topics Health)

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