Course description
This intensive one-day course provides a comprehensive introduction to ISO 13485, the internationally recognized standard for quality management systems (QMS) in the medical device industry. Designed for professionals seeking to understand the requirements and application of ISO 13485, this course covers key concepts, regulatory requirements, and practical implementation strategies.
Participants will gain insight into the standard’s structure, scope, and purpose, exploring how it aligns with other quality management systems and regulatory frameworks. Through a combination of presentations, discussions, and practical exercises, attendees will learn how to interpret and apply ISO 13485 requirements to enhance the quality and safety of medical devices.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Quality managers and auditors
- Regulatory affairs professionals
- Medical device manufacturers
- Consultants and trainers in quality management
- Any professional involved in the design, production, or distribution of medical devices
Outcome / Qualification etc.
Learning Objectives:
- Understand the purpose and benefits of ISO 13485.
- Familiarize with the structure and key clauses of the standard.
- Identify the regulatory requirements associated with ISO 13485.
- Learn how to implement a QMS based on ISO 13485 principles.
- Recognize the relationship between ISO 13485 and other standards like ISO 9001.
- Explore the certification process and what it entails for an organization.
Training Course Content
Course Outline:
- Introduction to ISO 13485:
- Overview of ISO 13485
- Importance and benefits of the standard
- Key terms and definitions
- Structure and Key Clauses:
- Detailed review of ISO 13485 structure
- In-depth analysis of key clauses
- Comparison with ISO 9001
- Regulatory Requirements:
- Understanding global regulatory landscape
- Aligning ISO 13485 with regulatory requirements
- Implementing ISO 13485:
- Steps to develop and implement a QMS
- Risk management and process control
- Documentation and record-keeping
- Certification Process:
- Overview of the certification process
- Preparation for certification audits
- Maintaining compliance post-certification
- Practical Exercises and Case Studies:
- Real-world examples and scenarios
- onteractive discussions and group activities
Course delivery details
Course Delivery:
- Duration: 1 day
- Format: Classroom or virtual
- Materials: Course manual, ISO 13485 standard excerpts, practical exercise templates
Assessment and Certification:
Participants will receive a certificate of completion at the end of the course, validating their understanding of ISO 13485 principles and their ability to apply these concepts within their organization.
Join us for this essential one-day course to ensure your organization meets the highest standards of quality and compliance in the medical device industry.
Expenses
Class Size and price: Up to 15 delegates £2,225.00
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