Fluorobiotech is proud to announce that we have officially been awarded ISO 13485 certification, a major achievement in our ongoing mission to enable high-quality, scalable biomanufacturing in Africa.
A Global Standard in Quality and Compliance
ISO 13485 is the internationally recognized standard for quality management systems specific to medical devices and related manufacturing, encompassing stringent requirements for process control, documentation, traceability, and regulatory compliance. For Fluorobiotech, this certification validates the robustness of our systems in the design, development, and production of recombinant enzymes and other critical molecular biology reagents.
Achieving ISO 13485 is more than a compliance milestone, it demonstrates to partners, customers, and the global biotechnology community that African-based manufacturers can deliver world-class, high-value products with consistency, reliability, and full regulatory rigor. It is a testament to our commitment to quality, precision, and continuous improvement across every aspect of our operations.
Acknowledging the Team Behind the Achievement
This accomplishment would not have been possible without the dedication and expertise of the entire Fluorobiotech team. We extend particular recognition to Etienne du Toit, our Quality Officer, whose guidance and meticulous oversight were instrumental in navigating the certification process.
The achievement also reflects the collective effort of our scientists, engineers, and operations staff, whose commitment to excellence ensures that Fluorobiotech continues to meet the highest standards in biotechnology manufacturing.
Strengthening Our Foundation for Growth
ISO 13485 certification strengthens Fluorobiotech’s foundation as we scale manufacturing capacity, expand the availability of essential bioprocessing tools, and support regional and global partners in developing innovative therapeutics, vaccines, and research reagents.
This milestone is a signal that Africa is ready to contribute world-class biotechnological solutions to the global supply chain, supporting both scientific innovation and public health initiatives across the continent.
With ISO 13485 certification in place, Fluorobiotech is well-positioned to pursue greater impact across biotechnology, healthcare, and molecular science, continuing to enable scientific innovation that is locally grounded and globally relevant.
Onward to the next chapter of growth, excellence, and impact in African biomanufacturing!