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Essentials of European Medical Device Regulations

(2 students)

This course includes:

02:26:00 hours

CPD Accreditation

4 units

Full lifetime access

Access on mobile and TV

Certificate of completion

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Key Concepts Covered by This Free Course:

  • Understand the European regulations on medical devices.
  • Identify the essential components of EU MDR.
  • Describe the reporting requirements and identification of medical devices.
  • Explain the quality system in medical device regulation.
  • Demonstrate knowledge of the EU MDR requirements for medical devices.
  • Develop strategies for compliance with the EU MDR.

Course Overview

The Essentials of European Medical Device Regulations course provides essential knowledge on the European regulations surrounding medical devices. Our comprehensive curriculum includes an overview of the regulations, the essential components of EU MDR, reporting requirements, identification of medical devices, and quality systems in medical device regulation. Our expert instructors provide engaging and interactive learning experiences, making this course accessible to anyone interested in learning about the EU MDR requirements for medical devices. Whether you are a medical device manufacturer, importer, or distributor, this course is essential to ensuring compliance and the safety of your products. This course is perfect for those looking to stay informed and up-to-date on the European regulations surrounding medical devices. Upon completion, you will have a solid understanding of the EU MDR requirements for medical devices, and the necessary skills to ensure compliance with the regulations.

Course Benefits

The Essentials of European Medical Device Regulations course offers a range of benefits to learners. By completing this course, you will have gained valuable knowledge on the EU MDR requirements for medical devices, reporting requirements, identification, and quality systems. Through interactive learning, you will develop the skills necessary to ensure compliance with the EU MDR and the safety of your products. With expert instruction, you will gain confidence in navigating the regulations and meeting the requirements. Moreover, this course is flexible, allowing you to learn at your own pace and in your own time. Upon completion of this course, you will be equipped with the knowledge and skills to navigate the European regulations surrounding medical devices, ensuring compliance and the safety of your products.

Career Path

  • Regulatory Affairs Specialist - Ensure medical devices meet regulatory requirements, including the EU MDR.
  • Quality Assurance Manager - Develop and implement quality systems to meet EU MDR requirements for medical devices.
  • Medical Device Compliance Officer - Ensure compliance with the EU MDR requirements for medical devices.
  • Clinical Research Associate - Manage clinical trials to ensure compliance with EU MDR requirements for medical devices.
  • Import/Export Compliance Manager - Ensure compliance with EU MDR requirements for medical devices during import/export activities.
  • Medical Device Sales Representative - Communicate the EU MDR requirements for medical devices to clients and customers.
Course content

Essentials of European Medical Device Regulations

01: Overview to European Regulations on Medical Devices

00:43:00

02: Essential Components of EU MDR

00:40:00

03: Reporting Requirements and Identification

00:27:00

04: Quality System in Medical Device Regulation

00:36:00

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