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Jenga Zetu Africa Ltd
Accredited by: KENAS
Jenga Zetu Africa Ltd, based in Kenya, is a product certification body accredited to ISO/IEC 17021-1:2015 standards. They specialize in certifying non-active medical devices, particularly those with measuring functions, under ISO 13485:2016 for medical device quality management systems. Their services are crucial for ensuring compliance and quality in the medical device sector within the region.
United Housing Estates,Opposite Gatura Gardens.Along Riara Rd,Off Ole Dume Road Nairobi County,Kenya.P.O.BOX 55086-00200,NAIROBI,KENYA,
Certification Scopes (2)
ISO 13485
Management System
Kenya Accreditation Service
Kenya
Jenga Zetu Africa Limited certifies organizations to ISO 13485:2016, focusing on quality management systems for medical devices. Their scope includes non-active, non-implantable medical devices, specifically those with measuring functions such as Objective Blood Measurement (OBM) drapes. This ensures compliance with international standards for safety and performance in the medical device industry.
ISO/IEC 17021-1
Management System
Kenya Accreditation Service
Kenya
Jenga Zetu Africa Limited certifies organizations under ISO/IEC 17021-1:2015, focusing on management systems for medical devices. They are authorized to certify non-active, non-implantable medical devices, specifically those with measuring functions such as Objective Blood Measurement (OBM) drapes. This certification ensures compliance with ISO 13485:2016 for quality management systems in the medical device sector.
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