Professional Certificate in 3D Printing: Healthcare Regulations
-- ViewingNowThe Professional Certificate in 3D Printing: Healthcare Regulations is a crucial course for professionals seeking to excel in the rapidly evolving 3D printing healthcare sector. This certificate program emphasizes the importance of regulatory compliance in 3D printing applications, a critical yet often overlooked aspect of this technology's integration into healthcare.
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โข Introduction to 3D Printing in Healthcare: Overview of 3D printing technology, its applications in healthcare, and the importance of regulatory compliance.
โข Regulatory Bodies & Guidelines: Examination of key regulatory bodies such as FDA, EU MDR, and China NMPA, and the guidelines they provide for 3D printing in healthcare.
โข Medical Device Classification: Understanding the classification of 3D printed medical devices and how it impacts regulatory requirements.
โข Design & Manufacturing Controls: Overview of design and manufacturing controls, including design inputs, design outputs, and design reviews, as well as manufacturing processes and equipment.
โข Materials Selection & Testing: Exploration of the importance of materials selection, testing, and validation in 3D printing for healthcare applications.
โข Sterilization & Packaging: Examination of sterilization methods and requirements, as well as packaging considerations for 3D printed medical devices.
โข Labeling & Traceability: Overview of labeling requirements and the importance of traceability in 3D printed medical devices.
โข Quality Management System: Understanding the role of a quality management system in ensuring regulatory compliance for 3D printed medical devices.
โข Clinical Evaluation & Post-Market Surveillance: Overview of clinical evaluation requirements and post-market surveillance for 3D printed medical devices.
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