About Us
QualiMan-Assist your partner in medical device regulatory compliance in South Africa
QualiMan-Assist is a consulting firm headquartered in Roodepoort, Johannesburg, South Africa. We assist South African registered companies, wishing to become medical device establishments, with compiling applications for submission to the regulatory authority / Regulator (SAHPRA). We also assist in medical device regulatory queries, as well as a compilation of medical device license amendment applications. Furthermore, we assist with the implementation/ maintenance of a medical device quality management system in accordance with the international standard, ISO 13485: 2016 Medical devices – Quality management systems – Requirements for regulatory purposes
