Software Design Controls Badge

Why Software Design Controls? Digitalization has rapidly advanced our ability to diagnose and treat patients around the world. We are seeing software in medical device (SiMD) and even software as the medical device itsel (SaMD)! There has been a huge call for putting the reigns on the “wild west” and ensuring that our use of software is safe, effective and responsible. Applying the design control strategy of traditional medical devices to these digital products is proving to be the answer.

Who Should Enroll? The Software Design Control Badge is intended to be an advanced course recommended for professionals who already have a baseline understanding of traditional computer software validation, computer software assurance and medical device design controls. 

What Will I Learn? Below, you will find each class listed with the Learning Objectives, Expert Instructors, and total course time needed to complete the program. You will learn how to navigate software complexities, integrate risk assessments, and ensure your product is designed with proper controls.

Digital Badge? Once you successfully complete the on-demand program, you will be awarded a Certificate of Completion and a Digital Badge that you can share on LinkedIn!

Meet Your Expert Instructor!

 
Featured
Eric Henry
Eric Henry

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice. King & Spalding

— 28+ years experience in industry
— Deep experience in Software Design Controls, Software as a Medical Device and Software in a Medical Device
— Design Controls leadership at Hologic, Boston Scientific, GE Healthcare, Medtronic and Philips
— Graduate lecturer at Temple University and frequent global conference expert presenter

 

The Curriculum:

Software Design Controls Badge: 10 Classes. 11 Videos. ~7.1 hours [.71 CEU]

Class 1: Introduction to Software Design Controls

Instructor: Eric Henry

Learning Objectives:

1. Become acquainted with various Software Design Controls terminology 2. Gain an appreciation of the complexity of global software regulation

 
 

Class 2: Software Development Planning

Instructor: Eric Henry

Learning Objectives:

  1. Gain an appreciation of developing a Software Development Planning strategy

  2. Understand some key elements to include in your plan

  3. Recognize the importance of linking the plan to a traceability approach

 

Class 3: Risk Management - Parts 1 and 2

Instructor: Eric Henry

Learning Objectives:

  1. Understand the importance of taking a holistic approach to Risk Management

  2. Distinguish between varying levels of risk and harm

  3. Understand P1 and P2

 

Class 4: Software Requirements, Architecture, and Design

Instructor: Eric Henry

Learning Objectives:

  1. Understand the major levels of software design

  2. Understand static means for verifying software design

  3. Learn how to build traceability into software design

 

Class 5: Software Verification

Instructor: Eric Henry

Learning Objectives:

  1. Understand the different levels of software verification

  2. Understand the impact of traceability on software verification

  3. Understand the test case structure in software verification

 

Class 6: Software Release, Validation and Traceability

Instructor: Eric Henry

Learning Objectives:

1. Understand the element of software release as distinct from design transfer

2. Understand software validation element for SaMD

3. Understand the importance and some mechanisms for full horizontal and vertical traceability

 

Class 7: Design Transfer and Maintenance

Instructor: Eric Henry

Learning Objectives:

1. Understand elements of design transfer specific to software

2. Understand the elements of a software maintenance plan

3. Understand the importance of and techniques for impact analysis during design change

 

Class 8: Software Problem Resolution

Instructor: Eric Henry

Learning Objectives:

1. Understand the elements of problem reporting

2. Understand the importance of problem trending

3. Understand the fallacy of zero-defect policies

 

Class 9: Legacy Software, Cybersecurity and Artificial Intelligence

Instructor: Eric Henry

Learning Objectives:

1. Understand how to integrate cybersecurity into design controls and risk management

2. Understand the regulatory requirements for cybersecurity

3. Understand AI/ML basics for medical devices

 

Class 10: Design Verification and Design Validation Knowledge Checks

Instructor: Eric Henry

Learning Objectives:

1. Understand key elements of design verification for SiMD/SaMD

2. Understand key elements of design validation for SiMD/SaMD

Pricing for On-Demand Badge:

How Will You Access the Course?

All Badge Courses are on-demand and are accessed through Pathway’s Learning Management System - Canvas.

  1. You will receive an email invitation from Canvas (notifications@instructure.com).

  2. You will create a Canvas log-in used for all Badges you take through Pathway.

  3. In Canvas, you will complete all classes in sequential order. After completing a quiz at the end of each class, the next class will be made available to you.

  4. After completing your course, you will receive your Certificate of Completion, which you can share as a Digital Badge on LinkedIn!

Interested in More? Quality Operations Forum

for Year Round Learning

If you are a Site or Corporate Quality Professional, you are invited to join our Quality Operations Forum.

  • You will have many opportunities throughout the year to learn from your global peers, Chief Quality Officers and experts from our industry and beyond.

  • The purpose of the forum is to support you in proactively implementing successful practices gained through a vibrant network of global peers collaboratively addressing contemporary and complex challenges.

  • 60+ World Cafe and External Intelligence meetings throughout the year are included!

Questions? Please contact Michelle Rich, our Director of Corporate Programs with any questions you might have.