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Clause 7 — Product Realisation

7.1 Planning of Product Realisation

7.2 Customer-Related Processes

7.3 Design and Development

7.4 Purchasing

7.5 Production and Service Provision

7.6 Control of Monitoring and Measuring Equipment

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Medical Devices – ISO 13485

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Welcome to "ISO 13485:2016 Clause 7: Mastering Product Realization and Control," the definitive online course designed for medical device professionals seeking to achieve excellence in quality management. Clause 7 is the heart of the ISO 13485 standard, governing how a medical device is brought from initial concept to a fully realized, compliant product ready for the market.

Welcome to "ISO 13485:2016 Clause 7: Mastering Product Realization and Control," the definitive online course designed for medical device professionals seeking to achieve excellence in quality management. Clause 7 is the heart of the ISO 13485 standard, governing how a medical device is brought from initial concept to a fully realized, compliant product ready for the market. In this comprehensive training, you will dive deep into the strategic integration of risk management, ensuring seamless alignment with ISO 14971 principles throughout the product realization lifecycle. Whether you are navigating complex customer-related processes, establishing robust design and development controls, or managing critical purchasing and supplier evaluations, this course provides the actionable insights you need. We will explore the nuances of production and service provision, including process validation, traceability, and the strict cleanliness requirements for sterile medical devices. Furthermore, you will master the control of monitoring and measuring equipment, ensuring your data is reliable and compliant. By the end of this course, you will possess the expertise to design, implement, and maintain rigorous product realization processes that not only meet regulatory expectations but also guarantee the safety and efficacy of your medical devices. Elevate your career and safeguard your organization's compliance with this essential ISO 13485:2016 training.

ISO 13485:2016 Clause 7 Explained

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            <p>ISO 13485:2016 Clause 7 represents the operational core of a medical device quality management system, encompassing the entire lifecycle from initial planning to the delivery and servicing of the device. For quality and regulatory professionals, mastering this clause is essential for ensuring that product realization processes are not only efficient but also strictly aligned with safety and performance requirements. This course provides an in-depth exploration of how to integrate risk management principles, specifically those outlined in ISO 14971, into every stage of the realization process. By establishing robust quality objectives and comprehensive verification and validation protocols, organizations can demonstrate a commitment to regulatory excellence and patient safety.</p>

<p>Throughout this curriculum, participants will analyze the critical interdependencies between customer requirements, design controls, and supplier management. We will examine the complexities of design transfer, the necessity of process validation in production, and the rigorous demands of traceability and contamination control. Furthermore, the course addresses the technical requirements for the control of monitoring and measuring equipment, including the validation of software used in these processes. Designed for engineers, project managers, and supply chain leaders, this training offers the practical insights and theoretical framework necessary to implement, maintain, and audit a compliant product realization system that withstands the scrutiny of international regulatory bodies.</p>
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