action medeor Tanzania Achieves ISO 13485-2016 Certification for Medical Device Quality Management
Written on December 4th, 2025
On December 4th, 2025, action medeor International Healthcare Tanzania proudly announced a significant achievement — our Quality Management System for Medical Devices has been independently assessed and found fully compliant with the internationally recognized ISO 13485:2016 standard.
This certification validates our processes in the design, development, and manufacturing of reagents and hematology analyzers, confirming that AMT operates at the highest level of quality, safety, and regulatory compliance required in the global medical device industry.
A Milestone Worth Celebrating
The news was met with great excitement and celebration across our teams. This success reflects years of dedication, continuous improvement, and strong teamwork among departments working to ensure that our products meet international standards and support reliable diagnostics across Tanzania and beyond.
Recognizing the People Behind the Success
This milestone was made possible through the commitment and expertise of the action medeor staff, with special recognition to:
Baraka Muro, Quality Assurance and Management Representative, whose guidance and coordination were central to the audit process.
Anneth Kimaro, Head of KTL and Laboratory Scientist, whose technical leadership and quality oversight strengthened the system.
Dr. Bernd Diener, Senior Expert of Health Technology from Germany, provided invaluable support and direction on compliance and technical excellence.
Their combined efforts ensured a smooth audit conducted by AXE Register and demonstrated our readiness for certification.
Commitment to Quality and Innovation
Achieving ISO 13485:2016 certification marks an important step for action medeor as we continue to invest in local manufacturing, laboratory technologies, and healthcare strengthening in Tanzania. This accomplishment enhances trust in our products and reinforces our mission to deliver safe, reliable, and high-quality medical solutions.
We extend heartfelt appreciation to our entire team, partners, and supporters who contributed to this milestone. Together, we continue advancing healthcare technology for a healthier tomorrow.