ISO 13485 Certification Training Course: Master Medical Device Quality Systems

Provided by: Professional Evaluation and Certification Board

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ISO 13485 Certification Training Course: Master Medical Device Quality Systems

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Course Overview

ISO 13485 certification is a globally recognized standard for quality management systems in medical devices. This course offers a comprehensive understanding of ISO 13485 compliance, regulatory requirements, and best practices.

Participants will learn how to implement ISO 13485 to ensure their organizations meet regulatory demands and enhance product safety. The training covers key topics including differences between ISO 13485 and FDA 21 CFR 820, risk management, documentation, and audit processes.

Target Audience

Quality Managers responsible
Regulatory Affairs Specialists
ISO 13485 Consultants
Medical Device Engineers
Internal & Lead Auditors
Manufacturing & Production Managers

Targeted Organizational Departments

Quality Assurance & Control
Regulatory Compliance
Manufacturing & Production
Research & Development
Supply Chain & Procurement

Targeted Industries

Medical Device Manufacturing
Pharmaceuticals & Biotechnology
Healthcare & Hospitals
Regulatory & Certification Bodies
Testing & Calibration Laboratories

Course Offerings

By the end of this course, participants will be able to:

Understand ISO 13485 standard requirements and its role in medical device quality assurance
Implement ISO 13485 best practices to enhance product safety
Conduct internal audits using the ISO 13485 audit checklist
Differentiate between ISO 13485 vs FDA 21 CFR 820 compliance requirements
Develop and manage ISO 13485 documentation requirements
Gain insights into ISO 13485 accreditation and certification steps
Become an ISO 13485 lead auditor or ISO 13485 lead implementer

Training Methodology

Case Studies: Real-world examples of ISO 13485 compliance failures & successes
Workshops & Exercises: Hands-on ISO 13485 certification training activities
Group Discussions: Peer-to-peer knowledge exchange on ISO 13485 QMS training
Mock Audits: Practice applying ISO 13485 audit training techniques

Course Toolbox

ISO 13485 implementation guide & templates
ISO 13485 compliance checklist for internal audits
ISO 13485 regulatory requirements reference guide
ISO 13485 certification exam prep materials

Course Agenda

Day 1: Introduction to ISO 13485 & Regulatory Framework

Topic 1: Overview of ISO 13485 certification and its importance in the medical devices industry
Topic 2: Understanding the medical devices quality management system (QMS)
Topic 3: Key regulatory requirements and compliance standards for ISO 13485
Topic 4: ISO 13485 vs FDA 21 CFR 820: Key differences and alignment strategies
Topic 5: ISO 13485 documentation requirements: Essential records and reports
Topic 6: ISO 13485 certification process: Step-by-step guide to implementation
Reflection & Review: Key takeaways, Q&A, and discussion on regulatory challenges

Day 2: Implementation of ISO 13485 Quality Management System

Topic 1: ISO 13485 standard requirements: Understanding the structure and clauses
Topic 2: Developing an ISO 13485 implementation guide for organizations
Topic 3: Risk management and preventive measures in ISO 13485 compliance
Topic 4: Internal audits and ISO 13485 compliance checklist for effective monitoring
Topic 5: Managing ISO 13485 accreditation and certification requirements
Topic 6: Integrating ISO 13485 with other quality standards for seamless compliance
Reflection & Review: Group activity and discussion on implementation challenges

Day 3: ISO 13485 Lead Auditor & Internal Audit Processes

Topic 1: Understanding the role of an ISO 13485 lead auditor and internal auditor
Topic 2: Preparing an ISO 13485 audit checklist for internal and external audits
Topic 3: Conducting ISO 13485 audit training: Key skills and techniques
Topic 4: Handling non-conformities and corrective action processes
Topic 5: Reporting and documentation of audit findings in ISO 13485 compliance
Topic 6: ISO 13485 certification exam preparation and mock assessment
Reflection & Review: Interactive session on audit best practices and case studies

Day 4: Advanced ISO 13485 Implementation & Process Optimization

Topic 1: Best practices for ISO 13485 QMS training and workforce development
Topic 2: Supplier management and control in ISO 13485 compliance
Topic 3: Enhancing medical device quality assurance through continuous improvement
Topic 4: ISO 13485 lead implementer strategies for effective QMS deployment
Topic 5: Documentation and record-keeping requirements for regulatory audits
Topic 6: Addressing ISO 13485 certification cost and budget considerations
Reflection & Review: Discussion on real-world implementation success stories

Day 5: Certification Exam & Practical Application

Topic 1: Final preparation for the ISO 13485 certification exam
Topic 2: Conducting a full-scale internal audit simulation
Topic 3: Common mistakes and challenges in ISO 13485 implementation
Topic 4: ISO 13485 consulting services and career opportunities
Topic 5: Developing a roadmap for ISO 13485 accreditation and long-term compliance
Topic 6: Continuous improvement and maintaining compliance post-certification
Reflection & Review: Course wrap-up, certification guidance, and Q&A

FAQ

What specific qualifications or prerequisites are needed for participants before enrolling in the course?

No prior certification is required, but experience in medical device quality assurance or ISO 13485 compliance is recommended.

How long is each day's session, and what is the total course duration?

Each session lasts 4-5 hours, with breaks and interactive discussions. The total course spans five days, approximately 20-25 hours.

What is the cost of obtaining ISO 13485 certification, and what factors affect it?

The ISO 13485 certification cost varies based on factors such as training provider fees, company size, and accreditation body charges. Contact us for detailed pricing.

How This Course is Different from Other ISO 13485 Training Courses

This ISO 13485 certification training goes beyond standard courses by offering:

Real-world case studies on ISO 13485 compliance
Hands-on exercises and mock audits for skill development
Training for roles like ISO 13485 lead auditor and internal auditor
Flexible online learning options

With expert trainers and a structured curriculum, this course prepares professionals for ISO 13485 accreditation and medical device industry certification.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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Phuket	Week 44, 2025 Nov 2, 2025 - Nov 6, 2025	5 Days	Onsite	€6,000
Muscat	Week 44, 2025 Nov 2, 2025 - Nov 6, 2025	5 Days	Onsite	€5,700
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