Title: About this Course
Course: PW-Course-Import-Test > Section: Course Introduction

Course Introduction

The Medical Device Industry is required to comply with 21CFR-820 federal regulations, and employees who work in the industry need to understand and be able to (at an entry level) describe and synthesize the various parts of the standard.

In this course you will master competencies related to the regulation and medical device quality systems. In particular, you will be able to describe regulations 21 CFR 820  ISO1345 and explain the consequence of non-compliance to the company and its employees. You will demonstrate the ability to assess situations of non-compliance and analyze the effects on a company.

The course is developed based upon medical device industry-recognized knowledge & skill standards. It is funded by a Department of Labor (DOL) TAACCCT grant for the Community College Consortium for Bioscience Credential (c3bc) and is focused on the students’ attainment of industry-recognized credentials to facilitate their employment and career upward mobility.

Delivery Model

This course is a fully online competency-based learning course. The course is asynchronous, meaning students enter and leave the course at different times. It is self-paced, so you may move through the material at your own pace on your own timetable within the parameters of the department.  Learning materials and instruction are designed to assist you toward mastery of the concepts and skills that will lead toward the competencies.

Course Competencies

Upon successful completion of this course, students are able to:

- Analyze the consequences related to CFR non-compliance of quality systems at a medical device company
- Explain the purpose of design controls with the medical device industry
- Identify key components of good document control requirements within the medical device industry
- Explain the purpose of production and process controls with the medical device industry
- Explain the purpose of a CAPA system and how it used in a regulated medical device environment
- Explain the significance of medical device record retention and controls
- Explain the principles and benefits of internal audits at a medical device industry
- Distinguish the key differences between the requirements of 21 CFR820 vs. ISO 13485

How This Course is Organized

The course is divided into eight modules (units) in addition this introduction. The modules are sequenced so you learn concepts and practice activities for the targeted competency and prepare to move on to the next competency (module). You can visit or revisit any module at any time. If you find that you are comfortable with your ability in one competency, you can move on without completing all activities. Keep in mind that the final objective exam and performance exam at the end of the course will assess your knowledge and ability related to all competencies in the course.

Each module includes videos, articles, examples, and links to resources and websites explaining the major concepts and one or more practice quizzes and learning community discussions. We encourage you to take the practice quizzes and participate in the discussions but they are not required.

The Learning Community Discussions will help you synthesize and gain a deeper understanding of the material. Read the Learning Community question prompt carefully and then post your answer or comment. You must post first before you can see other students’ comments and reply to their posts.

The short Practice Quizzes will help you check your understanding of key concepts. For each question, you will be instructed to either select the one correct answer, or select all correct answers, so pay special attention to each question instructions.

Be sure to read the syllabus for all details about this course.

Final Exams

You will complete two exams at the end of the course:

Objective Exam: A multiple-choice, computer-scored exam. You will take this exam in the Salt Lake Community College Testing Center at the Redwood Campus. You will have only two attempts to pass.

Performance exam: A multi-media presentation exam. You will prepare a narrated presentation and submit your presentation through a Canvas Assignments page. You will have only two attempts to pass.

You will find instructions for arranging for the final assessments in the Assessment module in Canvas.