Mastering Design Controls: An ISO 13485 Course for Medical Device Professionals

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This rigorous course/webinar offers comprehensive instruction on the design control requirements of ISO 13485:2016, which are now harmonized with the US Code of Federal Regulations (21 CFR Part 820) governing medical device development. Participants will gain the practical skills and critical knowledge needed to successfully establish, document, implement, and maintain design control processes, ensuring compliance and quality across the device's full lifecycle.

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This training takes place in one of two formats (your choice): 

• Three-day in-person training (8 hours/day) located at your site

• Five-day remote online training (4 hours/day)

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Design Controls for Medical Devices Course Objectives:

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After taking this course, you will be able to:

• Define the regulatory basis and requirements for Design Controls

• Apply Design Controls to device development in pre-market, design, and post-market phases

• Become familiar with the contents of a Medical Device File (MDF)

• Understand the interrelationship between Design Controls, Risk Management, and other sub-systems of the QMS

 

Who should take this course?

• Engineers and device team members new to their jobs

• Team members that require proof of training in Design Controls (certificate awarded at end of course)

• Experienced device professionals looking to brush up on regulations

• Recommended for professionals in QA/RA, R&D, Marketing, Production Management, and any role associated with the device development and maintenance function

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Course Overview

 

Introduction to Design Control

• Purpose of design control and when it begins

• Design control elements

• Requirements from US FDA and ISO 13485:2016

 

Design Control Planning

• Design control planning: Why, what, who, and how

• Project management

• Design review planning

 

Design Inputs

• Translate user needs to design inputs

• Translate design inputs to design specifications

 

Human Factors, Usability & Risk Management

• Usability and human factors in the design control process

• Links between design, usability, and risk management

 

Design Outputs and Design Reviews

• Design output requirements

• Traceability matrix

• Design review meetings

 

Design Verification

• Design verification process and methods

• Types of verification data

• Risk-based sampling

 

Design Validation

• Design validation process and methods

• Distinguishing between Process Validation and Design Validation

• Distinguishing between Design Verification and Design Validation

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Design Transfer & Medical Device Files

• Design transfer and documentation

• Design history file (DHF), device master record (DMR), device history record (DHR), and medical device file (MDF)

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Design Change

• Controlling design changes

• Documenting design change control

• Sources of design changes

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Post-market Design Controls Maintenance

• Maintaining design control documents after launch

• Post-market triggers of design controls process

 

Preparing for Design Audits

• FDA inspection techniques related to design controls

• MDSAP (Medical Device Single Audit Program) outcomes and linkages related to design and development process

• Best practices for audits and inspections

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