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Product Design Controls

Overview

Course Description

The course focuses on providing the student with a robust knowledge of design controls for medical devices according to international regulations and standards.

Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of the design control process (planning, inputs/outputs, review, verification and validation) in the medical device industry, ensuring regulatory compliance and addressing real-world challenges.

At The End Of The Course You Will Be Able To

  • Understand the steps and controls that involves  the medical devices design.
  • Associate the steps in the medical devices design process to the regulation and standard´ requirements.
  • Articulate an appropriate design process for a medical device.
  • Assess changes proposed to a medical device, based on the regulation´s and standards´ requirements.

Course Content

  1. General Process Overview
  2. Planning Design
  3. Input/outputs Design
  4. Review Design
  5. Verification Design
  6.  Validation Design
  7. Transfer Design

Description

The course focuses
on providing the student with a robust knowledge of design controls for medical
devices according to international regulations and standards.

Duration: 24 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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Course Features

The course focuses
on providing the student with a robust knowledge of design controls for medical
devices according to international regulations and standards.

Duration: 24 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

Ask for help

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This course helps students to understand the standards and regulations that apply to the packaging and labeling design, the necessary steps for design and testing, sterilization options and implications, materials and other main concerns for this interesting topic.

Duration: 24 hours

Modality: Group

Participant limit: 15

Download Course Technical Information