2018 – 2019
Florida Department of Education
Curriculum Framework 

Program Title: 		Medical Quality Systems
Specialization Tract:		Biomedical Systems
Career Cluster: 		Manufacturing

CCC	
CIP Number	0641010105	
Program Type	College Credit Certificate (CCC)	
Program Length	15 credit hours	
CTSO	SkillsUSA	
SOC Codes (all applicable) 	29-2071 – Medical Records and Health Information Technicians
31-9092 – Medical Assistants
29-2012 – Medical and Clinical Laboratory Technicians
51-9082 – Medical Appliance Technicians
11-9111 – Medical and Health Services Managers
17-2031 – Biomedical Engineers
19-4021 – Biological Technicians	
CTE Program Resources 	http://www.fldoe.org/academics/career-adult-edu/career-tech-edu/program-resources.stml	

Purpose

This certificate program is part of the Engineering Technology AS degree program (1615000001) under the Biomedical Systems specialization.  

A College Credit Certificate consists of a program of instruction of less than sixty (60) credits of college-level courses, which is part of an AS or AAS degree program and prepares students for entry into employment (Rule 6A-14.030, F.A.C.).

This program offers a sequence of courses that provides coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in the manufacturing career cluster; provides technical skill proficiency, and includes competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of the manufacturing career cluster. 

The content includes but is not limited to specialized courses used in the medical device manufacturing areas in quality assurance.

Additional Information relevant to this Career and Technical Education (CTE) program is provided at the end of this document.

Standards

After successfully completing this program, the student will be able to perform the following:

01.0	Demonstrate knowledge of the Food and Drug Administration (FDA) regulations and compliance for biomedical systems. 
02.0	Demonstrate knowledge in the design and manufacture of biomedical systems.
03.0	Demonstrate knowledge of risk management for biomedical products development and production.
04.0	Demonstrate knowledge of quality audits for biomedical systems.

2018 – 2019
Florida Department of Education
Student Performance Standards

Program Title:	Medical Quality Systems
CIP Number:	0641010105
Program Length:	15 credit hours
SOC Code(s):		29-2071, 31-9092, 29-2012, 51-9082, 11-9111, 17-2031, 19-4021

This certificate program is part of the Engineering Technology AS degree program (1615000001).  At the completion of this program, the student will be able to:	
01.0	Demonstrate knowledge of the Food and Drug Administration (FDA) regulations and compliance for biomedical systems--The student will be able to:	
01.01	Describe how the FDA is organized.	
01.02	Locate the Code of Federal Regulations (C.F.R.) specific to the FDA regulations that apply to biomedical systems manufacturers.	
01.03	Describe the role of the FDA’s standing advisory committee, the Center for Devices and Radiological Health (CDRH).	
01.04	Define medical devices, products, and systems and their federal classifications.	
01.05	Explain the 510(k) Premarket Notification Process including Applications (PMA).	
01.06	Explain an investigational device exemption (IDE).	
01.07	Explain the differences between Class I, II, and III devices.	
01.08	Describe and explain the Federal Food, Drug, and Cosmetic Act (FDCA).	
01.09	Define and describe good laboratory and clinical practices.	
01.10	Define and describe the quality system regulations (QSRs).	
01.11	Define and describe Current Good Manufacturing Practices.	
01.12	Define and describe foreign regulatory systems, i.e., the European Union (EU).	
01.13	Identify and explain the components of ISO 13485/ISO 13488.	
02.0	Demonstrate knowledge in the design and manufacture of biomedical systems–The student will be able to:	
02.01	Describe uses for which products could be designed.	
02.02	Apply the steps identified in the FDA’s regulatory requirements 21 CFR 820.30 Design Control.	
02.03	Describe the various product design methodologies and their associated lifecycles.	
02.04	Define, describe, and list product specifications.	
02.05	Describe, list, and apply failure modes and effects analysis (FMEA) to increase product safety.	
02.06	Demonstrate how various components of the design and development process effect reliability.	
02.07	Describe concurrent product and process development.	
02.08	Describe and compare installation and operation qualifications.	
02.09	Recognize process optimization.	
02.10	Develop and analyze process flow maps.	
02.11	Differentiate between verification and validation.	
02.12	Describe and determine how a design requirement is verified.	
02.13	Describe and analyze how customer needs are validated.	
02.14	Describe how a process output can be verified.	
02.15	Describe and analyze process capability.	
02.16	Define the terms associated with production scale-up.	
02.17	Describe and analyze production scheduling.	
02.18	Describe a market release package with multiple components.	
02.19	Determine a root cause of a problem is determined.	
03.0	Demonstrate knowledge of risk management for biomedical products development and production–The student will be able to:	
03.01	Describe the FDA’s definition of risk management.	
03.02	Explain how the subparts to the FDA’s regulatory requirements 21 CFR 820 Quality System Regulation (QSR) relate to risk management.	
03.03	Explain the process of identifying the key risk management activities critical to a successful risk management process.	
03.04	Explain the components of ISO 14971 and how they provide effective management of the risks associated with the use of medical devices.	
03.05	Explain how the components of risk management identified in ISO 14971 relate to the FDA’s Quality System Regulation (QSR).	
03.06	Develop a comprehensive risk management plan.	
03.07	Identify internal and external sources for determining product hazards.	
03.08	Estimate a risk using risk analysis tools and techniques.  	
03.09	Evaluate a risk using risk evaluation tools and techniques.	
03.10	Identify the steps associated with risk control.	
03.11	Identify the risk elements that can be reduced to decrease the risk associated with a hazard.	
03.12	Describe the process of verification and explain its role in risk control.	
03.13	Explain the relationship between risk control measures and the introduction of new hazards.	
03.14	Explain the difference between residual risk and overall residual.	
03.15	Develop a risk management report. 	
03.16	List and describe the elements of corrective action and preventive action (CAPA) associated with Post Production Information.	
04.0	Demonstrate knowledge of quality audits for biomedical systems–The student will be able to:	
04.01	Define terms associated with quality auditing.	
04.02	Describe the characteristics of internal and external quality audits.	
04.03	Describe the relationship between the quality audit and the FDA regulatory requirement 21 CFR 820.20 (c).	
04.04	List factors that can influence the credibility of quality audits.	
04.05	Describe the purpose and characteristics of a confidentiality agreement.	
04.06	Describe the auditor’s responsibilities when illegal or unsafe conditions or activities are discovered during an audit.	
04.07	Identify sources in a medical device manufacturing organization that generate performance history data for review prior to performing a quality audit. 	
04.08	Identify the quality auditing strategies for data collection.	
04.09	Describe the purpose and scope of the quality audit opening and closing meetings.	
04.10	Identify auditable quality records in a medical device manufacturing company as defined by the FDA regulatory requirements 21 CFR 820.180.  	
04.11	Describe the relationship of risk and criticality in analyzing audit data.	
04.12	Describe the difference between compliance issues and effectiveness issues and giving examples of each.	
04.13	Describe record retention requirements.	
04.14	Identify effective communication techniques that can be successfully used in a quality audit.	
04.15	Conduct a simulated audit that conforms to FDA regulatory requirements.	
04.16	Write a comprehensive audit report.	

Additional Information

Laboratory Activities

Laboratory investigations that include scientific inquiry, research, measurement, problem solving, emerging technologies, tools and equipment, as well as, experimental, quality, and safety procedures are an integral part of this career and technical program/course. Laboratory investigations benefit all students by developing an understanding of the complexity and ambiguity of empirical work, as well as the skills required to manage, operate, calibrate and troubleshoot equipment/tools used to make observations. Students understand measurement error; and have the skills to aggregate, interpret, and present the resulting data. Equipment and supplies should be provided to enhance hands-on experiences for students.

Career and Technical Student Organization (CTSO)

SkillsUSA is the intercurricular career and technical student organization for providing leadership training and reinforcing specific career and technical skills.  Career and Technical Student Organizations provide activities for students as an integral part of the instruction offered.  

Accommodations

Federal and state legislation requires the provision of accommodations for students with disabilities to meet individual needs and ensure equal access. Postsecondary students with disabilities must self-identify, present documentation, request accommodations if needed, and develop a plan with their counselor and/or instructors. Accommodations received in postsecondary education may differ from those received in secondary education. Accommodations change the way the student is instructed. Students with disabilities may need accommodations in such areas as instructional methods and materials, assignments and assessments, time demands and schedules, learning environment, assistive technology and special communication systems. Documentation of the accommodations requested and provided should be maintained in a confidential file.

Additional Resources

For additional information regarding Articulation Agreements; Bright Futures Scholarships; Fine Arts/Practical Arts Credit; and Equivalent Mathematics and Equally Rigorous Science Courses please refer to:

http://www.fldoe.org/academics/career-adult-edu/career-tech-edu/program-resources.stml