Design Controls for Medical Devices and IVDs Training


Virtual Learning
October 11 – 12, 2022

2 days


About This Course

This course provides an understanding of design control principles and the design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and EU MDR, as well as practical examples to maximize efficient executions and documentation practices.

Learn important requirements for medical devices and IVDs design controls, and benefit from open dialogue and sharing of current design and development processes highlighting how misperceptions of regulatory requirements have led to less-than-optimal practices. This course provides knowledge to assist in all phases of medical device design and development projects, as well as retrospective gap analysis of design history files, to help develop new technical files under the EU MDR and IVDR.

This instructor-led course is highly interactive and provides you with an understanding of the risk management definitions and principles of ISO 14971, and specifically addresses the regulatory expectations for medical device design control requirements.

Key Learning Objectives

Upon completion of this instructor-led medical device design controls course, you will be able to:

  • Properly identify design control requirements of the U.S. Quality System Regulation, EU MDR/IVDR and ISO 13485
  • Describe the design review, design verification and design validation processes
  • Understand the importance of the design history file (DHF)
  • Understand the links between design controls and risk management
  • Explain the design transfer process
  • Understand postmarket surveillance requirements in relation to design controls
  • Recognize potential exemptions from design control requirements
  • Graphically conceptualize a design control process

Who Should Attend

This class is vital for any medical device research and development professional, regulatory scientist and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.

Course Tutors

Course tutors selected from the following:

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

Deborah Baker-Janis - Deborah joined NSF in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes the development of pre‐clinical testing protocols and reports, risk documentation, quality system and regulatory affairs standard operating procedures, sales training materials, safety reports and domestic and international regulatory strategies and submissions.