Global Certificate in Next-Gen Medical Device Quality
-- ViewingNowGlobal Certificate in Next-Gen Medical Device Quality: A Comprehensive Course for Career Advancement This certificate course is designed to empower learners with the essential skills needed to thrive in the rapidly evolving medical device industry. It focuses on next-generation quality concepts, practices, and tools, addressing the growing industry demand for professionals who can ensure high-quality medical devices and compliance with stringent regulations.
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โข Medical Device Regulations: An overview of global regulations and standards for medical devices, including FDA, EU MDR, and ISO 13485.
โข Quality Management Systems: The foundation of a successful medical device quality program, including the key elements of a QMS and how to implement one.
โข Design Controls: The processes and procedures for designing medical devices, including risk management and verification and validation activities.
โข Document Control: The management of documents and records in a medical device organization, including document creation, review, and distribution.
โข Corrective and Preventive Action (CAPA): The processes for identifying, investigating, and resolving quality issues in medical device manufacturing.
โข Supplier Management: The management of suppliers and vendors in a medical device organization, including supplier selection, evaluation, and monitoring.
โข Change Management: The processes for managing changes to medical devices, including change identification, evaluation, and implementation.
โข Training and Competence: The development and implementation of training programs for medical device professionals, including the identification of training needs and the evaluation of training effectiveness.
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EntryRequirements
- BasicUnderstandingSubject
- ProficiencyEnglish
- ComputerInternetAccess
- BasicComputerSkills
- DedicationCompleteCourse
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- NotAccreditedRecognized
- NotRegulatedAuthorized
- ComplementaryFormalQualifications
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- ThreeFourHoursPerWeek
- EarlyCertificateDelivery
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- TwoThreeHoursPerWeek
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