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ISO 13485 is an international standard outlining the requirements for a Quality Management System (QMS) specific to the medical device industry. It's primarily aimed at manufacturers and distributors of medical devices.

Certification demonstrates your commitment to quality and safety, gaining trust from regulators, investors, and customers. In South Africa, as from April 2025, it will be mandatory to have a certified ISO QMS before renewing or obtaining a South African Health Products Regulator Authority Licence (SAHPRA).

Both address quality management but ISO 13485 is specifically tailored to the medical device industry, incorporating stricter requirements and focusing on risk management and regulatory compliance.