Medical Devices Industry Management System Audit Services | ISO 13485 & FDA/CE MDR Compliance – Angelstar

The medical devices industry is highly regulated, with global standards (ISO 13485) and regulatory requirements (FDA 21 CFR 820, CE MDR) mandating strict quality control, risk management, and traceability. For medical device manufacturers and foreign buyers, compliance is critical to ensure patient safety and market access. Angelstar’s specialized audit services for medical devices are delivered by experts with industry and regulatory experience.

1. ISO 13485 Quality Management Audit: Focus on design control, risk management (ISO 14971), production process validation, and product traceability.
2. Regulatory Compliance Audit: Verify compliance with FDA, CE MDR, and other regional medical device regulations.
3. Quality System Validation: Support validation of production processes, cleaning processes, and sterilization processes.
4. Post-Market Surveillance Audit: Evaluate post-market monitoring, complaint handling, and corrective/preventive actions.
5. Certification Support: Assist in preparing for FDA 510(k) submission and CE MDR certification.