Certificate in Global AM Regulatory Framework Interpretation
-- ViewingNowThe Certificate in Global AM Regulatory Framework Interpretation is a crucial course for professionals seeking expertise in the ever-evolving regulatory landscape of the Aerospace and Defense industry. This certification equips learners with the essential skills to navigate complex global regulations, ensuring compliance and driving success for their organizations.
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โข Global AM Regulatory Framework Overview: Understanding the international regulatory landscape for Advanced Medical devices and technologies. โข FDA Regulations for AM Devices: Exploring the Food and Drug Administration's regulations, processes, and requirements for AM medical devices. โข CE Marking for AM Devices: Examining the European Union's Conformitรฉ Europรฉene (CE) marking requirements for Advanced Medical devices. โข Japanese Pharmaceutical and Medical Device Regulations: Learning about the Japanese regulatory system for medical devices, including the Pharmaceutical and Medical Device Act (PMDA). โข Chinese Regulations for AM Devices: Understanding the China Food and Drug Administration (CFDA) regulations for Advanced Medical devices. โข Australian Therapeutic Goods Regulations: Exploring the Australian regulatory framework for Advanced Medical devices, including the Therapeutic Goods Administration (TGA). โข Canadian Medical Device Regulations: Examining the Canadian medical device regulations for Advanced Medical devices, including Health Canada's requirements. โข Global Harmonization and Standards for AM Devices: Investigating the international harmonization and standards for Advanced Medical devices, including ISO 13485. โข Clinical Evaluations and Trials for AM Devices: Learning about the clinical evaluation and trial requirements for Advanced Medical devices in the global market.
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- ProficiencyEnglish
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