What are the ISO13485 prerequisites? A quality management system must be in place to be certified for ISO. By Mohammed Jobran|2024-11-23T03:40:19+03:0023/11/2024|Iso13485| Share This Story, Choose Your Platform! FacebookXLinkedInWhatsAppTelegramEmail About the Author: Mohammed Jobran Regulatory Consultant (Pharmacist BSc, Biomedical Informatics MSc). With 19 years of experience working for SFDA, multinational companies, and as a professional consultant.