Sheridan Course Outlines

QUAL79020
Medical Devices Quality Assurance & Regulatory Affairs

Land Acknowledgement

Sheridan College resides on land that has been, and still is, the traditional territory of several Indigenous nations, including the Anishinaabe, the Haudenosaunee Confederacy, the Wendat, and the Mississaugas of the Credit First Nation. We recognize this territory is covered by the Dish with One Spoon treaty and the Two Row Wampum treaty, which emphasize the importance of joint stewardship, peace, and respectful relationships.

As an institution of higher learning Sheridan embraces the critical role that education must play in facilitating real transformational change. We continue our collective efforts to recognize Canada's colonial history and to take steps to meaningful Truth and Reconciliation.

Section I: Administrative Information

Total hours: 42.0
Credit Value: 3.0
Credit Value Notes: N/A
Effective: Fall 2020
Prerequisites: N/A
Corequisites: N/A
Equivalents: N/A
Pre/Co/Equiv Notes: N/A

Program(s): Professional Development for M
Program Coordinator(s): N/A
Course Leader or Contact: N/A
Version: 20200914_00
Status: Approved (APPR)

Section I Notes: This course includes online independent learning activities including reading, research, discussion board participation, and knowledge check quizzes. These must be completed each week prior to class to prepare for the weekly class lecture. Class lectures further explore and reinforce key learning concepts introduced in the online independent learning, through interactive and engaging activities including case studies, discussions, and experience sharing. For online discussion board participation, students are required to reflect on the course content and expand upon pre-assigned topics each week by actively contributing to the online text-based group dialogues. Online independent learning activities require a computer and reliable access to the internet as well as Sheridan's Learning and Teaching Environment (SLATE).

Section II: Course Details

Detailed Description
Students explore the innovative and rapidly expanding medical devices industry including roles and responsibilities from the Quality Assurance (QA) and Regulatory Affairs (RA) perspective. This highly interactive course draws upon real-life case studies as well as the expertise and experiences of instructors and guest speakers currently or previously working in the medical devices industry. Students learn how to interpret regulatory requirements and apply the key elements, processes, and best practices of a strategic risk-based QA/RA program required for timely regulatory clearance of safe and effective medical devices into Canada, USA and Europe markets. Students discover the core elements of a robust Quality Management System (QMS), including processes such as document and record management, design control, risk management, internal auditing, supplier management, complaint handling amongst others. Students learn to build effective communication and foster relationships to engage all stakeholders for QMS certification and regulatory compliance using international standards for medical devices (ISO 13485 and ISO 14971). Students acquire the required knowledge and skills to work with Health Canada, the US Food and Drug Administration (FDA), and European Notified Bodies.

Program Context

Professional Development for M	Program Coordinator(s): N/A
This course is part of the Professional Development for Medical and Health Services cluster of course offerings.

Course Critical Performance and Learning Outcomes

	Critical Performance:
	By the end of this course, students will have demonstrated the ability to apply the key elements of a strategic risk-based Quality Assurance (QA) and Regulatory Affairs (RA) program for timely regulatory clearance and entry of safe and effective devices into the Canadian, American and European markets.

Learning Outcomes:

To achieve the critical performance, students will have demonstrated the ability to:

Explain the key responsibilities of Quality Assurance (QA) and Regulatory Affairs (RA) in the context of the medical devices industry.
Interpret the regulatory requirements for target markets (Canada, the USA, and Europe) applicable to Class I and Class II (IIa/IIb in European Union) medical devices.
Explain the core elements required for a robust Quality Management System (QMS), including processes for: document and record management, design control, risk management, verification and validation, internal auditing, management reviews, supplier management, complaint handling,Corrective Action and Preventative Action (CAPA), and post-market surveillance.
Create a quality policy with well-defined, measurable quality objectives, which improves the effectiveness of the QMS, meets regulatory and customer requirements and aligns with organizational business objectives.
Determine whether risk management processes - including FMEAs (Failure Models and Effects Analysis) and hazard analyses - are planned and executed to improve product safety and meet regulatory requirements, in accordance with EN ISO/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
Determine whether all elements of design control - including traceability, and test methods - have been planned and executed in accordance with regulatory requirements.
Plan QMS certification and regulatory compliance activities including ISO 13485, Canadian Medical Devices Regulations (CMDR) compliance, 21 CFR Part 820 and Medical Devices Directives/Regulations (MDD/MDR).
Assess a medical devices manufacturer's level of conformance to internal and external QMS requirements via internal audits, management reviews, and supplier management controls.
Build effective communication relationships with internal stakeholders, suppliers and regulatory officials (Health Canada, US FDA and European Notified Bodies), to collaboratively resolve quality and regulatory challenges.
Summarize the key elements of a licence application, 510(k) submission, and technical file required for regulatory clearance and entry of safe and effective medical devices into target markets (Canada, the USA and Europe).
Analyze product history data (complaints, feedback and recalls) and Manufacturer and User Facility Device Experience (MAUDE) database reports, as part of ongoing post-market surveillance and reporting obligations.
Analyze new regulatory requirements, as part of ongoing regulatory intelligence responsibilities.

Evaluation Plan
Students demonstrate their learning in the following ways:

Evaluation Plan: IN-CLASS

	Online Knowledge Check Quizzes (3 x 5%)	15.0%
	Weekly Online Discussion Board Participation	10.0%
	Assignment 1	10.0%
	Assignment 2	15.0%
	Assignment 3	15.0%
	Class Presentation	10.0%
	Final Assignment	25.0%
	Total	100.0%

Evaluation Notes and Academic Missed Work Procedure:

Provincial Context
The course meets the following Ministry of Colleges and Universities requirements:

Essential Employability Skills
Essential Employability Skills emphasized in the course:

Communication
Critical Thinking & Problem Solving
Information Management
Interpersonal
Personal

Prior Learning Assessment and Recognition
PLAR Contact (if course is PLAR-eligible) - Office of the Registrar
Students may apply to receive credit by demonstrating achievement of the course learning outcomes through previous relevant work/life experience, service, self-study and training on the job. This course is eligible for challenge through the following method(s):

Portfolio
Notes: Portfolio, Resume, and Interview are all required for PLAR.
Interview
Notes: Portfolio, Resume, and Interview are all required for PLAR.
Other
Notes: Portfolio, Resume, and Interview are all required for PLAR.

Section III: Topical Outline

Some details of this outline may change as a result of circumstances such as weather cancellations, College and student activities, and class timetabling.
Instruction Mode: In-Class
Professor: Multiple Professors
Resource(s):

	Type	Description
Optional	Other	No textbook is used for this course. Recommended Reading: Articles, reading materials, and other learning assets will be available via SLATE, the Sheridan Library, or provided by the instructor.

Applicable student group(s): This is a specialized course intended for students who are interested in pursuing Quality Assurance (QA) or Regulatory Affairs (RA) career opportunities in the rapidly expanding Medical Devices industry. This course will appeal to students currently working in regulated industries such as Laboratory, Pharmaceuticals, Automotive, Aerospace, etc., who are interested in moving into the medical devices industry. This course will also appeal to students who want to acquire or strengthen QA and RA skills to help enable their organization's business objectives. Since all roles in a medical devices organization contribute to and are governed by the QA and RA program - required for timely regulatory clearance and entry of medical devices into markets - this course will also benefit students currently working or interested in working in Quality Control, Manufacturing, Engineering, Product Management, Marketing, and Senior Management of medical devices.
Course Details:

Module 1: Quality Assurance (QA) and Regulatory Affairs (RA) in the Medical Devices Industry

Welcome and Introductions, Course Overview, Training Environment, Expectations, Evaluation
The Medical Devices Industry and the Role of QA and RA
Key Requirements for Regulatory Clearance in Canada, the USA and Europe
Device Classifications and Regulatory Requirements across Canada, the USA and Europe

*Weekly Online Discussion Board Participation on Pre-Assigned Topics, throughout the course) - 10%

Module 2: Quality Management System (QMS) Requirements for Safe and Effective Medical Devices

Key Elements of a QMS
Benefits of Effective QA Oversight
Planning for ISO 13485 Certification
Building a Quality Culture that Enables Business Objectives

Module 3: Design Control throughout the Product Development Lifecycle (PDL)

Key Elements and Regulatory Requirements for Design Control
Maintaining Device History Records (DHR), Device Master Records (DMR) and Device History Files (DHF)
What is a Design Review and When is it Required?
How to meet Design Transfer Requirements utilizing the Traceability Matrix
Verification and Validation
Usability Engineering as a Core Design Control Tool

Assignment 1 Due (QA and RA Roles in the Medical Devices Industry) - 10%

Class Presentation - 10%

Module 4: Selecting and Managing Qualified Suppliers

Why is Supplier Management so Important?
Global Harmonization Task Force (GHTF) Guidance and Best Practices for Supplier Management
How to Select, Evaluate, Monitor and Control Suppliers Utilizing GHTF and ISO 19011:2011 Guidance Documents

Module 5: How Can I Help Reduce Risks to Patients, Users and My Organization?

Risk Management Processes outlined in EN ISO/ISO 14971
How does QA and RA Add Value to the Risk Management process?
Identifying, Evaluating and Controlling Risks
Key Elements of a Failure Mode and Effects Analysis (FMEA)
Challenges and Best Practices for Performing Risk-Benefit Analyses

Online Knowledge Check Quiz 1 - 5%

Module 6: Taking a Pulse: Internal Audits and Management Reviews

Managing Internal Audits
Creating a Regulation/Process Matrix
Quality Record Requirements for a Robust Internal Audit Program
How to Plan and Carry-Out Effective Management Reviews

Module 7: Complaint Management and the CAPA Process

The role of QA in Complaint Handling
Distinctions Between a Complaint, Inquiry, Service and Feedback
Corrective Action and Preventive Action (CAPA) Process
Handling a Medical Device Reporting Event
Complaint Trending Methods

Assignment 2 Due: (Design Control and Risk Management) - 15%

Module 8: What is Required to Sell Medical Devices in Canada and Europe?

How to Obtain a Medical Device Licence (MDL) and a Medical Device Establishment Licence (MDEL) in Canada
Canadian Medical Devices Regulations (CMDR)
European Medical Devices Directive (MDD 93/42/EEC)
European Union (EU) Competent Authorities, Authorized Representatives and Notified Bodies
Requirements for CE Marking under the European Regulatory Framework

Online Knowledge Check Quiz 2 - 5%

Module 9: What is Required to Sell Medical Devices in the USA?

US Food and Drug Administration (FDA) Quality System Requirements (QSR) and 21 CFR 820
510(k) Submission
Product Clearance
Registrations, Device Listings and the Investigational Device Exemption (IDE)

Module 10: Regulatory Audits and Inspections: Preparing For Successful Outcomes

Harnessing Stakeholder Support and Managing Expectations
Preparing for Inspections and Audits in Canada, the USA and Europe
Managing a Notified Body Un-Announced Audit
Handling Observations and Non-Conformances

Assignment 3 Due (Preparing a Regulatory Strategy) - 15%

Module 11: Post-Market Surveillance and Regulatory Changes

Key Post-Market Surveillance Activities
Sharing Post-Market Surveillance Data with Management
When is a Product Recall Required?
Tools To Monitor Post-Market Information (Regulatory and Product Changes)

Module 12: Final Assignment Preparation

Design a Plan to Position QA and RA as Enablers of Business Objectives

Online Knowledge Check Quiz 3 - 5%

Module 13: Enabling Expansion Into New Markets

Communicating Compliance Requirements to Management
Gaining Entry into Other Markets including Japan and China
Additional Requirements for Specialized Medical Devices in Europe
(Multiple) Languages Requirements, Translation Costs and Third-Party Test Laboratories

Module 14: How Can I Be More Effective In My Role?

Differentiating roles of Quality Control (QC) and Quality Assurance (QA)
Adding Value Without Being Considered as 'Policing'
Building Awareness and Competencies with Effective Communication and Training
Best Practices for Collaboratively Resolving QA and RA Challenges

Final Assignment Due (Design a Plan to Position QA and RA as Enablers of Business Objectives) - 25%

Sheridan Policies

It is recommended that students read the following policies in relation to course outlines:

Academic Integrity
Copyright
Intellectual Property
Respectful Behaviour
Accessible Learning

All Sheridan policies can be viewed on the Sheridan policy website.

Appropriate use of generative Artificial Intelligence tools: In alignment with Sheridan's Academic Integrity Policy, students should consult with their professors and/or refer to evaluation instructions regarding the appropriate use, or prohibition, of generative Artificial Intelligence (AI) tools for coursework. Turnitin AI detection software may be used by faculty members to screen assignment submissions or exams for unauthorized use of artificial intelligence.

Course Outline Changes: The information contained in this Course Outline including but not limited to faculty and program information and course description is subject to change without notice. Nothing in this Course Outline should be viewed as a representation, offer and/or warranty. Students are responsible for reading the Important Notice and Disclaimer which applies to Programs and Courses.

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