StimLabs Achieves ISO 13485:2016 Certification Signifying Quality Leadership in Medical Device Industry

StimLabs Achieves ISO 13485:2016 Certification

ROSWELL, Ga., Sept. 24, 2025 – StimLabs, a leading regenerative science pioneer, has proudly announced it has been granted the ISO 13485:2016 Certificate of Registration, a globally recognized standard denoting excellence in medical device quality management systems. This significant achievement reflects StimLabs' devotion to operational efficiency, patient safety, and innovation focused on quality.

This certification is vital as it situates StimLabs among an exclusive group of organizations meeting the highest quality standards in tissue banking and the design, development, and manufacturing of medical devices. Remarkably, within Georgia, StimLabs stands as the sole wound care device organization that boasts both AATB (American Association of Tissue Banks) accreditation and ISO 13485:2016 certification.

John Daniel, the Founder and CEO of StimLabs, remarked, "Achieving ISO 13485:2016 certification goes beyond mere regulatory compliance—it’s a testament to our enduring dedication to quality and the patients we serve. This revered standard enhances our capabilities for sustainable growth into newer markets and solidifies our standing as a trusted partner for hospitals, healthcare providers, and distributors, resulting in increased patient accessibility to advanced solutions."

With its ISO certification, StimLabs strengthens its influential position in the regenerative science field, continuously delivering breakthrough technologies that adhere to the safety, quality, and integrity demanded by the industry and patients.

About StimLabs

Founded in 2015, StimLabs is driven by its mission to innovatively enhance lives through regenerative science. The company is composed of industry leaders committed to providing patients with the utmost quality of care while addressing pressing needs in various clinical arenas. StimLabs boasts a comprehensive portfolio of products covering multiple clinical applications, all underpinned by a robust intellectual property framework. Dedicated to the delivery of superior solutions, StimLabs has established itself as a reliable partner for both physicians and patients.

For more information regarding StimLabs and its innovative offerings, visit www.stimlabs.com.