ISO 13485:2016 – Medical Devices Quality Management System (QMS) - ELITEMIND CONSULTANCY AND TRAINING

This course offers an in-depth understanding of ISO 13485:2016, the international standard that outlines the requirements for a quality management system specific to the medical devices industry. Participants will gain practical insights into how to design, implement, maintain, and improve a QMS that meets both regulatory requirements and customer expectations within the medical device lifecycle — from design and development to production, post-market activities, and servicing.

The course is especially tailored for professionals involved in the manufacturing, supply, and regulatory approval of medical devices, with a focus on risk management, traceability, and process validation.

By the end of this course, participants will be able to:
Understand the structure and requirements of ISO 13485:2016
Implement and maintain a compliant QMS for medical devices
Align internal processes with regulatory and customer requirements
Apply risk-based thinking to product design and manufacturing
Ensure traceability, process validation, and device safety
Conduct audits, management reviews, and improvement planning
Prepare for ISO 13485 certification or surveillance audits

Participants will receive:
ISO 13485:2016 training manual
Clause-by-clause interpretation guide
Sample QMS documentation and templates
Audit checklist and internal audit tools
Risk management and CAPA templates
Case studies and practical scenarios
Practice questions and exam prep guide
Certificate of completion (where applicable)

This course is ideal for:
Quality Managers and QMS Implementers in medical device companies
Regulatory Affairs Specialists
Internal and Lead Auditors
R&D and Product Design Engineers
Operations and Manufacturing Managers
Compliance Officers and Consultants
Professionals seeking ISO 13485:2016 certification

Course Content

1. Scope

2. Normative References

3. Terms and Definitions

4. Quality Management System
• - General Requirements • - Documentation Requirements

5. Management Responsibility
• - Management Commitment • - Customer Focus • - Quality Policy • - Planning • - Responsibility, Authority and Communication • - Management Review

6. Resource Management
• - Provision of Resources • - Human Resources • - Infrastructure • - Work Environment and Contamination Control

7. Product Realization
• - Planning of Product Realization • - Customer-Related Processes • - Design and Development • - Purchasing • - Production and Service Provision • - Control of Monitoring and Measuring Equipment

8. Measurement, Analysis and Improvement
• - General • - Monitoring and Measurement • - Control of Nonconforming Product • - Analysis of Data • - Improvement

Annex A: Correspondence Between ISO 13485:2016 and ISO 9001:2008 Bibliography

A course by

elitemindllc25@gmail.com

Student Ratings & Reviews

No Review Yet

Price:Free
Instructor:elitemindllc25@gmail.com
Lessons:0
Students:0
Level:All Levels

What Will You Learn?

Material Includes