Florida Department of Education
Curriculum Framework 

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

College Credit Certificate	
CIP Number	0641010105	
Program Type	College Credit Certificate (CCC)	
Program Length	15 credit hours	
CTSO	SkillsUSA	
SOC Codes (all applicable) 	For program SOC codes, please see the Program and Course Tables section of the CTE Program Resources page linked below.	
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.

Program Structure    

This program is a planned sequence of instruction consisting 15 credit hours.

When developing the course sequence for the local implementation of this program, select courses that:
•	Meet the skill development requirements of the standards and benchmarks of this program.
•	Where reasonable and practicable, align with programs offered by your institution or other postsecondary institutions in Florida, including: 
o	Related AS and AAS degrees.
o	Baccalaureate degrees within the same career pathway and/or Federal CIP code.

Visit FloridaShines’ Discover Programs website to identify other institutions that offer similar programs to review their course sequencing. Where appropriate, course alignment between institutions offering related programs can facilitate interagency student articulation.

Visit FloridaShines’ Common Prerequisites Manual to identify courses that are prerequisites for admission into an upper division program.  When sub-baccalaureate courses are aligned to the course admissions requirements of baccalaureate programs with the same career pathway, students can enter upper division coursework seamlessly.  

Florida’s Career Readiness Skills for CTE Programs

Employability Skills	
01.0	Apply academic skills to workplace scenarios.	
01.01	Use reading skills.	
01.02	Use writing skills.	
01.03	Use mathematical strategies and procedures.	
01.04	Use scientific principles and procedures.	
02.0	Design a solution to an industry problem.	
02.01	Use critical thinking.	
02.02	Use creativity.	
02.03	Make sound decisions.	
02.04	Solve problems.	
02.05	Reason. 	
02.06	Plan and organize.	
03.0	Manage resources within an industry project	
03.01	Manage time.	
03.02	Manage money or resources.	
03.03	Manage materials.	
03.04	Manage personnel.	
04.0	Oversee the subcomponents, operations and output of a technical or organizational system.	
04.01	Manage systems.	
04.02	Monitor systems.	
04.03	Improve systems.	
05.0	Use information for decision making.	
05.01	Locate information.	
05.02	Organize information.	
05.03	Use information.	
05.04	Analyze information.	
05.05	Communicate information.	
06.0	Apply relevant technology to workplace scenarios to aid productivity.	
06.01	Use technology.	
07.0	Interpret and express interpersonal communication.	
07.01	Communicate verbally.	
07.02	Listen actively.	
07.03	Comprehend written material.	
07.04	Convey information in writing.	
07.05	Communicate nonverbally.	
07.06	Interpret nonverbal communication.	
08.0	Interact with others to accomplish workplace goals.	
08.01	Collaborate with others in a team.	
08.02	Respond to customer needs.	
08.03	Exercise leadership.	
08.04	Negotiate to resolve conflict.	
08.05	Respect others.	
09.0	Manage personal behavior to maximize productivity and professional growth.	
09.01	Demonstrate responsibility and self-discipline.	
09.02	Adapt and show flexibility.	
09.03	Work independently.	
09.04	Demonstrate a willingness to learn.	
09.05	Demonstrate integrity.	
09.06	Demonstrate professionalism.	
09.07	Take initiative.	
09.08	Display positive attitude.	
09.09	Take responsibility for professional growth.	
Job Attainment	
10.0	Find, assess and apply to job opportunities.	
10.01	Identify online job posts relevant to his or her career aspirations.	
10.02	Compare and contrast the job posts’ required qualifications, job duties, compensation, benefits and employers. 	
10.03	Define what information, documentation and writing prompts are required for the positions.	
11.0	Communicate personal competence, character and fit for a job opportunity.	
11.01	Develop a resume.	
11.02	Write a cover letter.	
11.03	Curate a professional portfolio that includes work products.	
11.04	Prepare for and experience a mock job interview.	
12.0	Cultivate and leverage relationships to professionally advance.	
12.01	Request a signed reference letter, letter of recommendation and/or an online skill/professionalism endorsement. 	
12.02	Develop a plan to cultivate a professional digital footprint.	
12.03	Develop a networking plan for a specific industry of interest.	

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.

Florida Department of Education
Student Performance Standards

Program Title:	Medical Quality Systems
CIP Number:	0641010105
Program Length:	15 credit hours

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 (CFR) 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)

CTSOs are co-curricular career and technical student organizations 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. Other CTSOs not listed in this curriculum framework or recognized by the Florida Department of Education are permissible provided they support student mastery over the standards and benchmarks of this curriculum framework.

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.