ISO 13485: 2016 Internal Auditor Training

Program Title: ISO 13485: 2016 Internal Auditor Training on Quality Management System for Medical Devices

This training program provides an overview of the ISO 13485: 2016 standard, which specifies requirements for a quality management system (QMS) for medical devices. Participants will gain an understanding of the standard’s structure, key clauses, and regulatory requirements, and learn how it applies to the design, development, production, and maintenance of medical devices.

Why to Attend?

• Understand the core requirements and intent of ISO 13485:2016

• Learn how the standard supports regulatory compliance for medical devices

• Gain clarity on risk-based thinking, documentation, and process controls

• Understand roles and responsibilities within a medical device QMS

• Ideal starting point before implementation, internal audit, or certification

• Enhance organizational readiness for regulatory and certification audits

Who Can Attend?

• Medical Device Manufacturers & Start-ups

• Quality Assurance / Quality Control Professionals

• Regulatory Affairs Personnel

• Production, Process & Design Engineers

• Management Representatives

• Internal Auditors

• Consultants & Students aspiring to work in the medical device sector

• Suppliers & Service Providers to medical device manufacturers