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Design Control for Combination Products

When designing a new combination product, it’s important to have processes in place to avoid go-to-market difficulties.

Because of the additional complexity involved with combination products, once a manufacturer has determined that a proposed item has promise, it’s important that a design control plan should start immediately. Once established, the plan can be used to determine the adequacy of the design requirements and confirm that there are no negative interactions between its individual parts. The plan will also provide assurance that those parts, when combined, result in a combination product that performs as expected. In this class, you will learn how to apply control to the design process to ensure that your organization’s combination products meet user needs, intended uses, and specified requirements.

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Course Details

What Will You Learn

At the end of this workshop, you will be able to:

  • Identify design control regulatory requirements and standards applicable to combination products, including ISO 13485:2016, US FDA, ICH, and the EU Medical Device Regulation.
  • Describe a process model for design and development.
  • Describe the role of usability and human factors in the design control process.
  • Evaluate the links between design, usability, and risk management.
  • Describe design review, design verification, and design validation processes.
  • Identify strategies for risk-based sampling and statistical justification.
  • Describe best practices for the design transfer process.
  • Practice the design control process and building a design history file (DHF).
  • Describe postmarket surveillance and input to design changes.
  • Identify FDA inspection techniques (QSIT) related to design controls.
  • Identify MDSAP (Medical Device Single Audit Program) outcomes and linkages related to the design and development process.
  • Identify best practices in preparing for inspections and audits.

Who Should Attend

This course is appropriate for anyone managing, developing, reviewing, or engaging in the design of combination products. Recommended for those with direct engineering functions, QA/QC, production management, regulatory, and anyone else who has a role in building a robust regulatory-compliant environment.
  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Online Training Schedule

This class is delivered across 5 consecutive days. Sessions run daily from 1:00-5:00 p.m. (Eastern Time).

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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