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
🔹 Full ISO 13485:2016 System Implementation – Tailored to your device classification.
🔹 Risk Analysis for Medical Devices (ISO 14971:2019).
🔹 Internal Audits – Ensuring QMS compliance and certification readiness.
🔹 Ongoing Company & Process Support – Seamless workflow integration.
🔹 Application Submission Assistance – Supporting regulatory filings and approvals.
Our Previous experiences with ITA submission and approval:
Previously we have worked on ITA approvals on FTT sensor project with ICORD ( University of British Colombia). Our recent project for free flap tissue sensors which were assigned as class II medical devices. These sensors are supposed to examine oxygenation of the tissue.
Previously we have worked on ITA approvals on FTT sensor project with ICORD ( University of British Colombia)