Medical Device Safety, Standards and Regulation

BMT 120 introduces technicians to the critical aspects of medical device safety, national and international regulatory frameworks, and quality management systems. Students will gain a foundational understanding of electrical safety standards, including leakage current testing, and learn how device classification impacts regulatory oversight. The course addresses post-market surveillance, adverse event reporting, and device recalls, emphasizing their role in patient safety. Additionally, it explores key quality and safety concepts relevant to healthcare facilities. This curriculum is designed to equip technicians with the knowledge necessary to ensure compliance, maintain device integrity, and contribute to a safe healthcare environment without focusing on specific product brands or certification outcomes.

InstructorJacob Calhoun

Prerequisites

BMT 101

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Lesson 1: Introduction to Medical Device Safety and Regulationslecture

02Lesson 2: Overview of Electrical Safety Standards for Medical Deviceslecture

03Lesson 3: Understanding Protection Against Electric Shocklecture

04Hands-on Lab: Electrical Safety Testing Fundamentalslab

05Lesson 5: Medical Device Classification and Regulatory Pathwayslecture

06Lesson 6: Quality System Requirements for Medical Deviceslecture

07Lesson 7: Risk Management in Medical Device Lifecyclelecture

08Hands-on Lab: Leakage Current Measurement Techniqueslab

09Lesson 9: Post-Market Surveillance and Adverse Event Reportinglecture

10Lesson 10: Medical Device Recalls and Corrective Actionslecture

11Hands-on Lab: Documentation and Reporting for Device Safetylab

12Lesson 12: Healthcare Facility Accreditation and Safety Conceptslecture

13Lesson 13: Ethical Considerations and Professional Responsibilitieslecture

14Capstone Service Project: Medical Device Safety Audit and Improvement Planassignment

Syllabus

["Week 1: Lesson 1: Introduction to Medical Device Safety and Regulations","Week 2: Lesson 2: Overview of Electrical Safety Standards for Medical Devices","Week 3: Lesson 3: Understanding Protection Against Electric Shock","Week 4: Hands-on Lab: Electrical Safety Testing Fundamentals","Week 5: Lesson 5: Medical Device Classification and Regulatory Pathways","Week 6: Lesson 6: Quality System Requirements for Medical Devices","Week 7: Lesson 7: Risk Management in Medical Device Lifecycle","Week 8: Hands-on Lab: Leakage Current Measurement Techniques","Week 9: Lesson 9: Post-Market Surveillance and Adverse Event Reporting","Week 10: Lesson 10: Medical Device Recalls and Corrective Actions","Week 11: Hands-on Lab: Documentation and Reporting for Device Safety","Week 12: Lesson 12: Healthcare Facility Accreditation and Safety Concepts","Week 13: Lesson 13: Ethical Considerations and Professional Responsibilities","Week 14: Capstone Service Project: Medical Device Safety Audit and Improvement Plan"]