Design and Development for Medical Devices and IVDs

  • Overview
  • On-Site Training
  • Virtual Training
  • Who Should Attend?
  • Trainer Profile

As part of NSF’s medical devices training and regulatory support services, our team of experts provides a hands-on and interactive course focused on design and development. This two-day course provide you with an understanding of the actual risk management and design and development regulatory requirements relative to FDA’s 21 CFR 820, ISO 13485:2016 and the new EU device regulations, as well as practical examples of how to minimize inefficient executions and documentation practices. The greatest benefit of this course is gained through open dialogue and sharing of current design and development processes to highlight how misperceptions of regulatory requirements have led to less than optimal practices. This course provides you with knowledge to assist in all phases of your design and development projects, medical devices regulatory strategy and retrospective gap analysis of design history files in preparation for the development of new technical files under the EU MDR and IVDR.

On-Site Training

Upon completion of this two-day medical devices training course, you will be able to:

  • Identify regulatory requirements for risk management
  • Recognize risk management definitions and principles of ISO 14971
  • Identify regulatory requirements for design and development projects
  • Recognize regulatory expectations relative to design and development requirements
  • Explore methods of optimization while still meeting regulatory requirements and intent

Virtual Training

NSF International’s two-hour web-based virtual training course provides a basic understanding of design controls for medical devices and in vitro diagnostic products (IVDs).  Our experts provide knowledge to comply with U.S. FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016 and the European Union Medical Device Regulation (EU MDR).  Learn from global quality systems expert, Kim Trautman, a former U.S. FDA official who authored the current U.S. FDA Quality System Regulation and is a recognized leader in continued global regulatory harmonization efforts.

At the end of this course you will be able to:

  • Identify design control requirements based on U.S. FDA Quality System Regulation, ISO 13485:2016 and EU MDR
  • Recognize how risk management ties into the design control process
  • Recognize FDA’s auditing process and expectations for design controls
  • Identify appropriate application of design control requirements

Following the course, you will have a 20-question exam to assess your competency of the material. Upon successful completion, you will receive a Certificate of Successful Completion that can be added to your company’s training file.

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Who Should Attend?

This class is vital for any medical device R&D engineer, scientist and clinician as well as regulatory affairs and quality assurance professionals.

Trainer Profile

NSF's medical devices training courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainers for this course:

Upcoming Courses & Webinars

In Design and Development for Medical Devices and IVDs
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