Definition: International standard for Quality Management Systems specific to medical devices. Ensures consistent design, development, production, and distribution of safe medical devices.
Why It Matters: Required for organizations involved in medical device cold chain. SAHPRA alignment with international standards makes ISO 13485 essential for medical device logistics providers.
Cold Chain Relevance:
– Temperature-sensitive medical device storage and transport
– In-vitro diagnostics requiring refrigeration
– Biological products and reagents
– Implantable devices with specific storage requirements
Key Requirements:
– Risk management throughout product lifecycle
– Design and development controls
– Measurement, analysis, and improvement
– Regulatory compliance (SAHPRA in South Africa)
Related Terms: SAHPRA, GDP, Medical Device, Quality Management System