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 Quality Policy, SOPs, Work Instructions, and CAPA Procedures.
✅ Ensure compliance with FDA 21 CFR Part 820, EU MDR, and other local regulations.
2️⃣ Risk Management & Process Validation
✅ Implement ISO 14971-based risk management for medical devices.
✅ Conduct Failure Mode and Effects Analysis (FMEA) for product safety.
✅ Validate production processes, software systems, and sterilization methods.
3️⃣ Supplier Audits & Material Traceability
✅ Establish a supplier qualification & audit program for critical materials.
✅ Ensure full traceability of raw materials & components used in manufacturing.
✅ Implement automated supplier performance tracking for non-conformities.
4️⃣ Internal Audits & Certification Readiness
✅ Conduct risk-based internal audits to verify process compliance.
✅ Prepare for ISO 13485 certification with a gap analysis & mock audit.
✅ Select an accredited ISO 13485 certification body for the final audit.