Global Certificate in Medical Device Quality Regulations
-- ViewingNowGlobal Certificate in Medical Device Quality Regulations: A Comprehensive Course for Career Advancement in the Medical Device Industry. This certificate course is designed to empower learners with a deep understanding of global quality regulations in the medical device industry.
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โข Global Medical Device Quality Regulations Overview: Understanding the legal and quality frameworks governing medical devices on a global scale.
โข ISO 13485:2016: Comprehensive review of the international quality management system standard for medical devices.
โข Quality Management Principles: Exploring the fundamental principles that form the basis of effective medical device quality management.
โข Regulatory Affairs Management: Managing regulatory affairs for medical devices, including registration, compliance, and post-market surveillance.
โข Risk Management in Medical Devices: Implementing and maintaining risk management processes in accordance with ISO 14971.
โข Medical Device Design Control: Understanding the design and development controls for medical devices as per FDA and ISO requirements.
โข Good Manufacturing Practices (GMPs): Adhering to GMPs for medical devices, ensuring compliance with regulations and industry best practices.
โข Clinical Evaluation and Technical Documentation: Preparing and maintaining technical documentation and clinical evaluation reports for medical devices.
โข Labeling and Packaging Requirements: Compliance with global labeling and packaging regulations for medical devices.
โข International Regulatory Compliance: Overview of regulatory frameworks in major markets, including FDA (USA), MHRA (UK), TGA (Australia), and SFDA (China).
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