Industries: Medical Device

Design Control for Medical Device Professionals

Course Director: Wen Schroeder

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

Course Description -

This course focuses on introducing the students to the regulatory requirements stipulated under the US Medical Device Quality Systems Regulation.  Each of the seven key elements of Design Control compliance will be briefly reviewed.  In addition, specific GMP requirements, submission dossier preparation throughout the Design Control lifecycle and submission strategy will be discussed.

This Design Control course is US-focused.  The students will gain a fundamental understanding of how medical devices are regulated in the US:  the main legal basis, FFDCA (21 U.S.C. 301) and the specific Medical Device Quality Systems Regulation, and the comparison/contrast of the GMP requirements imposed on the medical devices and pharmaceutical products in the US.  In addition, the students will be introduced to a brief overview of relevant global regulatory framework including the EU MDR 2017 and the latest ISO standards (ISO 13485:2016).

Grounded on the codified Quality Systems Regulation, the US FDA outlines seven major building blocks for the Design Control of medical devices:  User needs, Design inputs, Design process, Design outputs, Design verification, Design Validation, and Design Review.  This Design Control course covers all aspects of these seven building blocks for the purpose of providing the students with a clear picture of the entire design control process and corresponding regulatory compliance requirements.  Additionally, this course places more emphasis at the front end of developing a medical device:  user needs, inputs vs. outputs, human factors, documentation/history files/record keeping requirements, etc.

Who Should Attend

This course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing an understanding of Design Control per the FDA's CFR 820.30.  The course also provides context for 820.30 vs. the Design Control part of ISO 13485:2003. 

Personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of the Design Control, and its workings, will benefit from this course. Additionally, this program can be customized and delivered on-site for more experienced personnel (including middle and upper management) to update and broaden their knowledge of the FDA's Design Control requirements.

First Day

Introduction to Design Control

  • Design Control in Context to Medical Device Design and Engineering Practice
  • Background of FDA regulation (law)
  • Discussion of FDA guidelines (recommendations)
  • Class I, II, and III device discussion
  • FDA vs. ISO 13485 aspects

Quality System Aspects

  • Quality System Framework – Where does Design Control Fit
  • Quality system strategy for compliance with Design Control
  • Typical quality system procedures, forms, and records relating to Design Control

Key Concepts

  • The Framework for Risk Management
  • Controls and Records
  • Key Definitions

Integrated Risk Management

  • Importance of effective design philosophy for performance and safety
  • Operational Considerations and Usability
  • Considerations for interoperability
  • Use of international standards
  • Effective use of risk management techniques
  • Discussion of risk management procedure

Second Day

Implementing Top Level Design Control Procedure

  • Requirement #1: Intended Use
  • Requirements based approach to design control
  • Examples of requirements models
  • Project planning
  • Discussion of various document types – requirements, specifications, design documents, plans, test documentation, drawings, design documents, traceability matrices, design review minutes, and risk analyses.

Validation and Verification (V&V)

  • Definitions
  • Strategies considerations for validation
  • Strategies considerations for verification
  • Design Reviews
  • Statistical techniques
  • Procedural discussion for V&V, design reviews, statistical methods
  • Requirements for managing prototypes, including units scheduled for field

Software Considerations

  • Discussion of FDA software guidelines
  • Special considerations for software
  • Software improvement models
  • Discussion of software development methods

Manufacturing Transfer

  • Integrating manufacturing considerations into design
  • Documentation for Design History Files vs. Device Master Record (manufacturing documents and procedures), techniques to minimize duplication
  • Product vs. process considerations
  • Discussion of process validation
  • Discussion of manufacturing transfer procedure

Integrating General Quality Procedures in Design Control

  • Documentation control procedures
  • Configuration management/change control procedures
  • Training procedures
  • Auditing procedures
  • Equipment calibration

Learning Objectives

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

  • Describe the legal basis & industrial standards regulating the manufacture of medical devices.
  • Gain an understanding of the regulatory framework for Design Control and recommendations to effectively meet the requirements of Design Control.
  • Describe general regulatory requirements pertaining to design control within the quality system and regulation, design control procedures, safety/risk management, documentation, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.
  • Outline steps and tools to establish and implement effective design controls and quality management system.


"Excellent course! The Course Director was extremely knowledgeable and excellent delivery of course material." Andrew H., QA Group Leader, Advanced Medical Solutions
"All of the course content was very good as it reflected what is carried out in my organization." Jonathan F., Quality Engineer, BD
"Good details on key aspects including being up-to-date with MDRs, etc." Vincent N., Head of Innovation, Terumo Aortic
"Course addressed a variety of useful and interesting topics. Covered all aspects of design control. Interesting and challenging exercises." Andrew R., Scientific & Regulatory Affairs Manager, MLT Research Ltd
"This course was extremely thorough. Design controls are now completely understood. The course was extremely informative. The instructor knew the topic and passed on his knowledge. All things were presented in a professional and excellent manner. The Course Director is a wonderful teacher." Christine W., Design Drafter, Biomet
"The Course Director was very knowledgeable of the design control process. He answered all my questions thoroughly." Angela W. , Sr. Product Development Engineer, Surgical Specialties
"I came into the course wondering how I could link design control concepts to QC testing of reagents in a diagnostic test that is being developed in my company. I feel that the course material and the way in which it was taught definitely helped me understand how I can get my job done more efficiently and what is really required in order to adequately assess various risk management issues as they relate to the above mentioned diagnostic test." Thomas V., Product Development Scientist III
"Excellent course. Small number of students was very helpful in engaging in discussion, etc." Andrew B., Senior Regional Auditor, Pfizer U. K.
"This course was a real eye-opener for many of our Design Team. The exercise with statistics for validation was fantastic and will really help us with validation. Thank you!" Patricia H., Quality Technician, Tecan Systems
"The course was very concise and the instructor was very knowledgeable. I would recommend this highly. There was a good general understanding for FDA manufacturing requirements." Greg V., Quality Assurance Engineer, Roche
"The templates were tremendously helpful. The Course Director's suggestions on methods to develop clear design inputs, and the emphasis on the importance of clear design inputs, were very useful." Julie W., Validation Team, Biomimetic Therapeutics

Frequently Asked Questions

Is the course different than the Design Validation, Verification, and Risk Analysis Course?

Yes. The Design Validation, Verification, and Risk Analysis course provides a deeper, narrower, and more strategic look at the topics of Validation, Verification, and Risk Analysis as compared to the Design Control course. The Design Control course covers greater breadth and a more comprehensive overall view of Design Controls. The two courses are intended to be complimentary.

Does the course also ISO 13485-2003?

The course does discuss the relationship between the ISO 13485-2003 and FDA's 21 cfr part 820 regulation. After a comparison is established, the course materials follow FDA's 21 cfr part 820.30 references partly because the regulation and the corresponding guidance documents are publicly available without purchase.

What materials come with the course?

A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents and procedures.

Are there particular types of medical devices emphasized?

No. A wide variety of medical device types are affected by the regulation, thus a broad view is presented.

Are any other topics covered outside of Design Control?

A short but broad overview of key medical device regulations that relate in some way to Design Controls are presented in order to provide additional context for the course.