QMS ISO 13485:2016 Implementation
ISO 13485:2016 is the globally recognized standard for Quality Management Systems (QMS) tailored to organizations involved in the lifecycle of medical devices, including design, development, production, installation, and servicing.
Key Steps in ISO 13485:2016 Implementation
✅ Aligning QMS with Regulatory Requirements – Compliance with FDA 21 CFR Part 820, EU MDR, and other global regulations.
✅ Establishing Clear Documentation – Defining device specifications, procedures, and quality control measures.
✅ Conducting Risk Assessments (ISO 14971:2019) – Ensuring proactive hazard identification and mitigation.
✅ Maintaining Traceability – Comprehensive tracking of materials, components, and final products throughout the device lifecycle.
Our Services
🔹 Implementing the Complete ISO 13485:2016 System – Customized based on device classification.
🔹 Providing Risk Analysis for Medical Devices (ISO 14971:2019).
🔹 Performing Internal Audits – Ensuring QMS compliance and readiness.
🔹 Supporting the Company & Its Processes – Seamless integration into existing workflows.
🔹 Application Submission – Assisting with regulatory filings.
