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ISO 13485 Medical Devices

Overview

Course Description

The objective of the course is to provide students with the understanding of the ISO 13485:2016 and the quality management systems requirements which are essential to organizations involved in the design, production, installation and servicing of medical devices and related services.

Through hands-on activities and case studies, students will gain valuable experience in navigating compliance challenges and addressing quality management issues.

At The End Of The Course You Will Be Able To

  • Understand the general connection and differences between the ISO 13485 and the 21 CFR Part 820.
  • Know key factors to comply and maintain compliance to the ISO 13485.
  • Understand how a company’s quality management system fulfils and is connected to the ISO 13485.
  • Learn to interpret ISO 13485 general requirements in the specific context of the medical device industry.
  • Understand how the company’s quality management system fulfils and is connected to the ISO 13485.
  • Learn the general requirements from each clause of the ISO13485 and how they correlate to the company quality system and procedures.
  • Experience and apply ISO 13485 requirements to solve real case situations during the class that a professional in this industry could face to maintain compliance.

Course content

  1. Overview
  2. Quality management system
  3. Management responsibility
  4. Resource management
  5.  Product realization
    • Planning of product realization
    • Customer-related processes
    • Design and development
    • Purchasing
    • Production and service provision
    • Control of monitoring and measuring equipment
  6. Measurement, analysis, and improvement
    • Monitoring and measurement
    • Control of nonconforming product
    • Analysis of dataImprovement

Description

Learn about the requirements associated to the ISO 13485 Standard.

Duration: 4 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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Course Features

Learn about the requirements associated to the ISO 13485 Standard.

Duration: 4 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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