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Este producto está disponible en un envase tipo botella con un peso neto de 530 g y se ofrece en unidades por pack, también limitadas a una unidad

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Number of Vials:1 Vial

What You’ll Learn * The structure and purpose of ISO 13485 and its relevance to medical device quality assurance * How to interpret and apply the standard’s key clauses: Quality Management System, Management Responsibility, Resource Management, Product Realization, and Measurement & Improvement * How to build ISO 13485-compliant documentation: quality policies, manuals, objectives, SOPs, work instructions, and records * Best practices for implementing quality controls throughout the device lifecycle—from design and development to delivery * How to prepare for and conduct internal quality audits and management reviews * How to meet global regulatory requirements and foster a culture of quality and accountability Who This Course is For This course is ideal for: * Quality Assurance & Regulatory Affairs professionals working in MedTech * Medical device engineers, designers, and developers * Compliance officers, auditors, and consultants * Healthcare entrepreneurs and startup founders aiming for ISO 13485 certification * Students and career changers entering the medical or quality sector * Anyone responsible for creating or maintaining a quality system in a medical device company Whether you're building a QMS from scratch or improving an existing system, this course gives you the tools to succeed