East African Medical Vitals (EAMV) announces that it has received ISO 13485:2016 certification for Medical Devices. This certification is required for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
ISO 13485 certified means that the EAMV Quality Management system is appropriate and effective whilst emphasizing the safety and efficacy of medical devices.
This certification demonstrates our unwavering commitment to quality and allows East African Medical Vitals to continue developing medical consumables that meet the highest standards for safety, product performance, and reliability.
ISO 13485:2016 is an internationally recognized quality standard that was created to provide a quality framework for the consistent design, development, servicing, and sale of medical devices. It is based on the ISO 9001 process model approach. Manufacturers seeking certification must demonstrate their ability to comply with the standard’s requirements through documented procedures and supporting evidence.
About East African Medical Vitals
East African Medical Vitals (EAMV) is a leading medical consumables manufacturing firm in Sub-Saharan Africa, providing long-term, sustainable access to high-quality, safe, and affordable medical consumables.
EAMV is committed to manufacturing and delivering high-quality products that comply with all local, regional, and international certifications and standards.
Located in Namanve Industrial Area, Uganda, the plant has a production capacity of 5,000 pairs per hour, resulting in a total of 3,000,000 surgical and examination medical gloves every month.
