JC Auditors’ Managing Director, Oliver Naidoo, was recently interviewed by Gareth Edwards, the eNCA Anchor on the topic of ISO 13485 medical device certification. In this engaging conversation, Oliver Naidoo explained how the ISO 13485 standard is used to promote safety and efficacy of medical devices in the enabling health care practitioners deliver the highest levels of patient care. ISO 13485 certification is a key milestone for manufacturers and distributors in the medical field. It signifies commitment to the highest quality standards, ensuring the safety and effectiveness of medical devices on the market.
South African Health Products Regulatory Authority (SAHPRA) have included ISO 13485 certification as a regulatory requirement for the issue of medical device licences, with effect from 1 April 2025. Oliver Naidoo’s expertise and insights during the interview underscored JC Auditors’ dedication to assisting organizations in meeting these new regulatory requirements most efficiently. The JCA medical device team has a deep understanding of ISO 13485, and we are well-prepared to guide and support businesses on their journey to compliance.
Over the last 15 years, JC Auditors have an established reputation as a leading certification body in quality management systems and regulatory compliance. We are committed to providing the guidance and expertise needed to navigate these changes successfully, helping our clients continue to deliver safe and effective medical devices to the market. Watch the full interview below The South African Medical Technology Industry Association (SAMED) SALDA Medical Device Manufacturers of South Africa #ISO13485 #SAHPRA #MedicalDevices #QualityManagement #RegulatoryCompliance #Expertise #IndustryLeadership #Healthcare #QualityAssurance
