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iso 13485 certificationISO 13485 Certification: Ensuring Quality in Medical Devices ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry. It sets out the requirements for an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory demands. ISO 13485 certification is a critical step for...0 Комментарии 0 Поделились 497 Просмотры
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iso 13485 internal auditor trainingISO 13485 Internal Auditor Training What is the ISO 13485 Standard? ISO 13485 is an international standard that specifies requirements for a quality management system for the design and development of medical devices. ISO 13485 Internal Auditor Training is a course that provides participants with the knowledge and skills necessary to perform internal audits of quality management systems...0 Комментарии 0 Поделились 366 Просмотры
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iso 13485 internal auditor trainingISO 13485 Internal Auditor Training What is the ISO 13485 Standard? ISO 13485 is an international standard that specifies requirements for a quality management system for the design and development of medical devices. ISO 13485 Internal Auditor Training is a course that provides participants with the knowledge and skills necessary to perform internal audits of quality management systems...0 Комментарии 0 Поделились 261 Просмотры
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ISO 13485 Internal Auditor Training: Ensuring Quality in Medical Device ManufacturingIntroduction ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. It ensures that organizations consistently meet regulatory and customer requirements while maintaining the highest standards of safety and performance. Internal auditors play a critical role in ensuring compliance with...0 Комментарии 0 Поделились 613 Просмотры
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ISO 13485 trainingAbout ISO 13485 Lead Auditor Training ISO 13485 Lead Auditor Training is a comprehensive program that provides participants with the skills and knowledge necessary to perform lead audits for medical device companies against ISO 13485. The course covers the requirements of ISO 13485, auditing principles, and techniques specific to medical device companies. Participants will learn how to plan...0 Комментарии 0 Поделились 193 Просмотры
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ISO 13485 trainingWhat is ISO 13485? ISO 13485 is a quality management system standard that is specific to the medical device industry. It helps manufacturers create products that are safe and effective for patients. To receive ISO 13485 certification, a company must demonstrate that it has a comprehensive quality management system in place. This system includes processes for the design, development,...0 Комментарии 0 Поделились 326 Просмотры
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ISO 13485 Training: Building Competence for Medical Device QualityIntroduction In the highly regulated medical device industry, ensuring product safety, efficacy, and compliance with global standards is paramount. ISO 13485:2016, the international standard for quality management systems (QMS) specific to medical devices, provides a framework for organizations to meet these demands. However, implementing and maintaining an effective QMS requires a deep...0 Комментарии 0 Поделились 535 Просмотры
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ISO 45001 Management: Building Safer, Compliant, and Sustainable EnterprisesIntroduction: Why ISO 45001 Management Matters Now Workplace health and safety is no longer just a compliance requirement; it is a cornerstone of sustainable business growth. For organizations in the life sciences and manufacturing sectors, ensuring occupational health and safety can directly impact operational performance, regulatory readiness, and brand reputation. ISO 45001 management...0 Комментарии 0 Поделились 5 Просмотры