A well-structured QMS integrates systems, processes, and people, ensuring compliance with international standards like ISO 13485 and national regulations such as those outlined by the South African Health Products Regulatory Authority (SAHPRA). This article explores the significance of these three pillars—systems, processes, and people—in building and maintaining an effective QMS for medical device distributors.
ISO13485 Certification
SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified by the time that they renewed their Medical Device Establishment Licenses for a further three years.