Inspection, Regulations and Compliance

This course provides a comprehensive overview of the regulatory landscape for laboratory microscope service and maintenance. Students will delve into critical standards such as those governing healthcare facilities and electrical safety, understanding their direct application to optical equipment. Emphasis is placed on preparing for external inspections, meticulous record-keeping, and the protocols for incident reporting and recalls. The curriculum integrates practical sessions on safety testing and documentation, ensuring graduates are well-versed in compliance requirements. This knowledge is crucial for ensuring device safety, operational integrity, and organizational accountability within clinical and research laboratory settings, preparing technicians for complex regulatory environments.

InstructorJacob Calhoun

Prerequisites

MIC 101 MIC 105 MIC 110

Course outline

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

01Lesson 1: Introduction to Regulatory Compliance in Laboratory Settingslecture

02Lesson 2: Overview of NFPA 99 and Its Application to Medical Equipmentlecture

03Lesson 3: Electrical Safety Standards for Laboratory Microscopy Systemslecture

04Hands-on Lab: Electrical Safety Testing Techniques and Equipment Operationlab

05Lesson 5: Understanding Joint Commission Requirements for Medical Deviceslecture

06Lesson 6: CMS Regulations and Their Impact on Laboratory Microscope Servicelecture

07Lesson 7: Documentation Best Practices: Service Records and Logbookslecture

08Hands-on Lab: Comprehensive Electrical Safety Testing & Midterm Reviewlab

09Lesson 9: Incident Reporting Protocols and Root Cause Analysislecture

10Lesson 10: Product Recalls: Identification, Response, and Remediationlecture

11Hands-on Lab: Mock Inspection Preparation and Documentation Auditlab

12Lesson 12: Quality Assurance and Continuous Improvement in Service Operationslecture

13Lesson 13: Ethical Considerations and Professional Conduct in Compliancelecture

14Capstone Service Project: Comprehensive Compliance Plan Developmentassignment

Syllabus

["Week 1: Lesson 1: Introduction to Regulatory Compliance in Laboratory Settings","Week 2: Lesson 2: Overview of NFPA 99 and Its Application to Medical Equipment","Week 3: Lesson 3: Electrical Safety Standards for Laboratory Microscopy Systems","Week 4: Hands-on Lab: Electrical Safety Testing Techniques and Equipment Operation","Week 5: Lesson 5: Understanding Joint Commission Requirements for Medical Devices","Week 6: Lesson 6: CMS Regulations and Their Impact on Laboratory Microscope Service","Week 7: Lesson 7: Documentation Best Practices: Service Records and Logbooks","Week 8: Hands-on Lab: Comprehensive Electrical Safety Testing & Midterm Review","Week 9: Lesson 9: Incident Reporting Protocols and Root Cause Analysis","Week 10: Lesson 10: Product Recalls: Identification, Response, and Remediation","Week 11: Hands-on Lab: Mock Inspection Preparation and Documentation Audit","Week 12: Lesson 12: Quality Assurance and Continuous Improvement in Service Operations","Week 13: Lesson 13: Ethical Considerations and Professional Conduct in Compliance","Week 14: Capstone Service Project: Comprehensive Compliance Plan Development"]