Comprehensive ISO 13485 Training: Ensuring Medical Device Quality and Compliance

Duration:

2 Days (16 hours)

Target Audience:

• Quality assurance professionals
• Regulatory affairs personnel
• Medical device manufacturers
• R&D teams
• Consultants and auditors

Prerequisites:

Basic understanding of quality management systems (QMS) or ISO standards.

Course Objectives:

By the end of the training, participants will:

1. Understand the principles and requirements of ISO 13485:2016.
2. Learn how to implement and maintain an ISO 13485-compliant quality management system.
3. Gain insights into the regulatory framework and risk management in the medical device industry.
4. Develop the skills needed to conduct internal audits and address non-conformities.
5. Explore documentation best practices for compliance and certification readiness.

Learning Outcomes:

Upon successful completion of the course, participants will be able to:

1. Describe the purpose and structure of ISO 13485 and its relevance to the medical device industry.
2. Identify the key clauses of ISO 13485 and explain their practical application.
3. Design and implement a QMS that meets ISO 13485 requirements.
4. Conduct internal audits and support external audits for ISO 13485 compliance.
5. Apply risk management principles aligned with ISO 14971 and integrate them into the QMS.
6. Manage and control documentation, including records and procedures.

Course Methodology:

The training will employ a mix of:

1. Lectures & Presentations:
   • Interactive slides covering ISO 13485 principles, clauses, and real-world applications.
2. Case Studies:
   • Analysis of practical scenarios and challenges faced by medical device companies.
3. Group Activities:
   • Collaborative exercises to identify risks, conduct gap analysis, and propose QMS improvements.
4. Workshops:
   • Hands-on practice in drafting documentation, developing processes, and auditing.
5. Quizzes & Assessments:
   • Knowledge checks to evaluate understanding of key concepts.
6. Q&A Sessions:
   • Opportunities for participants to seek clarification and discuss specific challenges.
7. Mock Audits:
   • Simulated audit exercises to prepare participants for real-world application.

Course Outline:

Day 1: Understanding ISO 13485

1. Introduction to ISO 13485
   • Importance and scope
   • Relationship with other standards (e.g., ISO 9001, ISO 14971)
2. Overview of the Medical Device Regulatory Environment
3. Clause-by-Clause Breakdown
   • Context of the organization
   • Leadership and planning
   • Support and operation
4. Risk Management in ISO 13485
   • Aligning with ISO 14971

Day 2: Implementation & Auditing

5. Implementation Strategies
   • Gap analysis and transition planning
   • Developing compliant processes
   • Documentation management
6. Auditing Essentials
   • Principles of internal auditing
   • Common non-conformities and how to address them
7. Certification Process
   • Preparing for external audits
   • Maintaining compliance post-certification
8. Closing Workshop
   • Group presentations and feedback