Next Biosciences’ state-of-the-art laboratory is situated in Midrand, Gauteng.
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Our laboratory is ISO 13485 accredited and licensed by the Department of Health in South Africa.
The stem cell laboratory is accredited by the Association for the Advancement of Blood and Biotherapies (AABB) and the biological products Next Biosciences produces are licensed by SAHPRA.
AABB (Association for the Advancement of Blood and Biotherapies) standards consist of both quality and technical elements of blood banking, transfusion medicine and cellular therapies – cord blood banking being one of their main competencies. The accreditation assures that a cord blood bank complies with minimum acceptable requirements.
Next Biosciences has obtained ISO 13485 registration from Lloyd’s register Internationally, certifying that our quality management system for the “processing, storage, testing and distribution of human biological material” has met the international standard for the quality management of medical devices.
Next Biosciences has been granted Authorised Institution Status by the Department of Health, South Africa. Next Biosciences is authorised in terms of regulations R.183 of RG No. 9699 of 2 March 2012 to acquire, preserve, process, store and distribute stem cells.
Next Biosciences is licensed to manufacture medical devices by the South African Health Products Regulatory Authority (SAHPRA). The medical device unit of SAHPRA regulates the licencing of establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) to ensure acceptable levels of safety, quality and performance.