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

QualiMan-Assist has professionals who are ready to assist you with your medical device related regulatory work in order to comply with the local Regulator’s requirements as well as the international standard. Our team is comprised of pharmacists and personnel with various other degrees who are dedicated and willing to go the extra mile in ensuring that your regulatory needs are met.

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