ISO 13485:2016 – Medical Device Quality Management System (QMS) Implementation
ISO 13485:2016 is the international standard for medical device quality management systems. It ensures compliance with regulatory requirements (FDA, EU MDR, MDSAP, etc.) and focuses on risk management, traceability, and process validation. 🔑 Key ISO 13485 Requirements 1️⃣ QMS Documentation & Regulatory Compliance ✅ Establish a QMS aligned with ISO 13485 & regulatory requirements.✅ Develop […]