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Medical Device Design Control Training

Design controls are integrated management practices applied to the medical device development process, ensuring that the resulting device is safe, effective, and meets stakeholder requirements. In this class, you’ll learn strategies and best practices for managing these processes, thus ensuring that your organization’s devices meet user needs, intended uses, and specified regulatory requirements, including US FDA, ISO 13485, the Medical Device Single Audit Program (MDSAP) and the European Medical Device Regulation (MDR 2017/745).

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Brief Overview of this Medical Device Design Control Class with a Focus on FDA, ISO 13485 & MDSAP Requirements

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person*

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Design Control Training Classes

SkillsLab $3295

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
DBF VIRTUAL DELIVERY (Eastern Time) 24 Jun 2024 28 Jun 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
DBF San Jose, Costa Rica 24 Jun 2024 26 Jun 2024 8:00AM - 5:00PM CR In-Person REGISTER
DBF San Diego, CA 05 Aug 2024 07 Aug 2024 8:00AM - 5:00PM Pacific US Time In-Person REGISTER
DBF VIRTUAL DELIVERY (Eastern time - PM) 26 Aug 2024 30 Aug 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
DBF VIRTUAL DELIVERY (Eastern time - PM) 28 Oct 2024 01 Nov 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
DBF San Jose, Costa Rica 12 Nov 2024 14 Nov 2024 8:00AM - 5:00PM CR In-Person REGISTER
DBF VIRTUAL DELIVERY (Eastern time - PM) 16 Dec 2024 20 Dec 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Class on Medical Device Design Controls

The pace of change and the iterative nature of most design processes make understanding when and how to apply design controls even more important. Learn how to apply control to the design process to ensure that your organization’s devices meet user needs, intended uses, and FDA, ISO 13485, & MDSAP requirements. 

Course Overview
SkillsLab Class

Introduction to Design Control

  • Purpose of design control and when it begins
  • Design control elements
  • Requirements from US FDA and ISO 13485:2016
Exercise! Identify a Product 

Design Controls and Design Process

  • The elements of a process
  • The process model for design and development
  • Design process efficiency
Exercise! Your Process

Design Control Planning

  • Design control planning: Why, what, who, and how
  • Project management
  • Design review planning
Exercise! Design Control Plan

Human Factors, Usability, and Risk Management

  • Usability and human factors in the design control process
  • Links between design, usability, and risk management
 

Design Inputs, Outputs, and Reviews

  • Translate user needs to design inputs
  • Design input and output requirements
  • Traceability matrix
  • Design review execution
Exercise! Populate Fields in a Traceability Matrix

Design Verification

  • Design verification process and methods
  • Layers of verification
  • Risk-based sampling
Exercise! Verification Methods

Design Validation

  • Design validation process and methods
  • Layers of validation
Exercise! Validation Methods

Design Transfer and Design Files

  • Design transfer and documentation
  • Design history file (DHF), device master record (DMR), device history record (DHR), and medical device file (MDF)
Exercise! Create a DMR

Change Management

  • Design changes and control
  • Configuration management
  • Document control and change control
  • Postmarket sources of design changes (FDA and EU MDR)
Exercise! Impact Assessment 

Auditing the Design and Development Process

  • FDA inspection techniques (QSIT) related to design controls
  • MDSAP (Medical Device Single Audit Program) outcomes and linkages related to design and development process
  • Audit and inspection best practices
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Identify design control regulatory requirements and standards

Describe a process model for design and development

Evaluate the links between design, usability, and risk management

Describe design inputs, design outputs, design review, design verification, and design validation

Identify strategies for risk-based sampling and statistical justification

Describe best practices for the design transfer process

Describe postmarket surveillance and input to design changes

Identify best practices in preparing for inspections and audits

Practice design control activities in workshops

Who Should Attend

Who Should Attend

Recommended for anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, regulatory, and anyone else who has a role in building a robust regulatory-compliant environment. 

  • Design Engineers
  • RA/QA Professionals
  • Product Managers
  • Project Managers
  • Software Engineers 

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