Learning Objectives
By the end of this training, you will be able to:
- Explain the context, purpose, and structure of the ISO 13485:2016 standard and describe how it relates to Regulation (EU) 2017/745 (MDR).
- Organize the documentation for a Quality Management System (quality manual, procedures, records) in accordance with the standard’s documentation requirements.
- Identify management’s responsibilities (commitment, management review, strategic planning) to ensure the effective management of the QMS.
- Organize the management of human resources, physical resources, and the work environment to meet quality requirements.
- Describe the requirements for the manufacture of medical devices (planning, design, procurement, production, and product risk management).
- Implement the measurement, analysis, and continuous improvement tools (metrics, internal audits, nonconformities, corrective and preventive actions) of a QMS that complies with the standard.
- Quality Manager
- Regulatory Affairs Manager
- Project managers, R&D, production, quality control, or supply chain managers.
- Any person involved in the implementation, maintenance, or improvement of an ISO 13485 quality system.
- A general understanding of the medical device industry, quality standards, or applicable regulatory requirements is a plus.
- Prior experience with ISO 13485 is not required
- Format: virtual or in-person class
- In-house training available: please contact us
- Registration deadlines: Registration closes 24 hours before the session. Maximum of 10 people. Minimum of 3 people.
- Accessibility: Accessible to everyone. If you require special accommodations due to a disability, please contact us.
Training Program
- Background and Objectives of the ISO 13485 Standard.
- Why is a quality management system (QMS) essential?
- Development and implementation of a tailored QMS.
- Document Management: Quality Manual, Procedures, Records – Best Practices and Compliance.
- Management Commitment: Responsibilities and Leadership in Quality.
- Strategic Planning and Executive Review: Aligning Quality with Business Objectives.
- Build skills and raise awareness among teams.
- Ensure that the infrastructure and work environment meet quality requirements
- Plan and monitor each stage of the production cycle.
- Identify and manage product-related risks to ensure safety and compliance
- Process and Product Monitoring: Key Performance Indicators.
- Using data to drive continuous improvement.
- Feedback, internal audits, nonconformity management, and corrective/preventive actions.
Monitoring and Evaluation Procedures
- Attendance Sheet
- Mini quiz / practice exercise at the end of each learning objective
- Final Review Quiz at the End of the Training Course
- Satisfaction Survey
- Training Certificate
Technical and Educational Resources
- Technical Requirements: Microphone, webcam, and internet connection required; a Microsoft Teams link will be sent 24 hours before the workshop.
- Methods Used: Training materials provided to trainees by the instructor. Practical exercises, discussions, and sharing of experiences.
Speaker
Medical Device Trainer: Significant professional experience in the field of medical devices >5 years.
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