Design Controls Under QMSR 

Design controls sit at the center of the Quality Management System Regulation (QMSR). They govern how medical devices are planned, built, and documented — and they receive close scrutiny in FDA inspections. Despite appearing straightforward on paper, design controls carry real complexity in practice. This course builds a working understanding of the design control process, the phases of design, and design change control, using practical examples drawn from the medical device development environment. 

At a Glance 

• Total Length of Course: 1 hour  

• RAC Points: 1 point 

• This course was developed by Michelle Lott and Tianna Benson from LeanRAQA 

Learning Objectives 

Upon completion of this course, participants should be able to: 
 

• Navigate design control requirements under QMSR and ISO 13485:2016 

• Implement a structured design control process from concept through transfer 

• Define intended use, indications for use, and user needs more effectively 

• Write measurable design inputs that support verification and validation 

• Build traceability between user needs, design inputs, outputs, and testing activities 

• Conduct documented design reviews with cross-functional participation 

• Distinguish verification from validation and understand when each applies 

• Evaluate design changes for regulatory impact and risk management implications 

• Maintain documentation that supports audit readiness and regulatory inspections 

Lesson Titles 

• Lesson 1: Introduction to Design Controls Under QMSR 

• Lesson 2: Design Control Process 

• Lesson 3: Phase Design: Planning, Intended Use and User Needs 

• Lesson 4: Phase Design: Design Inputs, Outputs, and V&V 

• Lesson 5: Design Change Control

This course is also included in:
QMSR Effectiveness Bundle