DMI 463 - Medical 3D Printing Quality Assurance and Regulations
This course provides an in-depth exploration of quality assurance and regulatory requirements for medical 3D printing. Students will learn the critical aspects of ensuring the safety, efficacy, and reliability of 3D printed medical devices. Topics include quality management systems, validation and verification processes, risk management, and adherence to FDA and international regulations. The course also covers standards for materials and processes, documentation and reporting requirements. Through case studies and practical exercises, students will develop the skills necessary to implement and manage quality assurance practices in medical 3D printing, ensuring compliance with regulatory standards and promoting patient safety.
Semester hours: 3.0