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Essentials of European Medical Device Regulations

5-in-1 Bundle | CPD Accredited | Interactive Learning Materials | Free PDF Certificate | Tutor Support | Lifetime Access


Cambridge Open Academy

Summary

Price
£35 inc VAT
Study method
Online
Duration
3 hours · Self-paced
Access to content
Lifetime access
Qualification
No formal qualification
CPD
10 CPD hours / points
Certificates
  • Certificate of Completion (PDF) - Free
  • Certificate of Completion (Hard Copy) - £9.99
Additional info
  • Exam(s) / assessment(s) is included in price
  • Tutor is available to students

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Overview

Did you know that the European Medical Device Regulations are pivotal in ensuring the safety and efficacy of medical devices? With the ever-evolving landscape of healthcare, understanding the Essentials of European Medical Device Regulations is paramount. This comprehensive course, comprising four modules, offers an in-depth exploration of these crucial regulations, equipping you with the knowledge you need to navigate this intricate field.

Learning Outcomes:

  • Understand the key principles underpinning European Medical Device Regulations.
  • Identify and explain the essential components of EU MDR.
  • Comprehend the reporting requirements and their significance in ensuring safety.
  • Gain insights into the quality system integral to medical device regulation.

This Bundle Consists of the Following Courses:

  • » Course 01: Essentials of European Medical Device Regulations
  • » Course 02: Medical Law
  • » Course 03: Different Types of Anaesthesia
  • » Course 04: Biomedical Science
  • » Course 05: Safe Handling of Medicines

CPD

10 CPD hours / points
Accredited by CPD Quality Standards

Course media

Description

Delve into Module 01 for an overview of European regulations on medical devices, grasping the foundation of the industry. Module 02 breaks down the essential components of EU MDR, while Module 03 focuses on reporting requirements and product identification. Lastly, Module 04 delves into the quality system that forms the backbone of medical device regulation. No matter your background or expertise, this course ensures that you'll possess the knowledge necessary to thrive in the ever-evolving world of European medical device regulations.

Join us on a journey through the Essentials of European Medical Device Regulations, and unlock the potential of this booming sector. Whether you're new to the field or seeking to deepen your knowledge, this course is for you. Enrol today and be well-prepared to excel in the dynamic landscape of medical device regulation.

Course Curriculum:

  • Module 01: Overview to European Regulations on Medical Devices
  • Module 02: Essential Components of EU MDR
  • Module 03: Reporting Requirements and Identification
  • Module 04: Quality System in Medical Device Regulation

Who is this course for?

  • Aspiring professionals looking to enter the medical device regulatory sector.
  • Current industry experts seeking to deepen their understanding of European regulations.
  • Quality assurance professionals in the medical device field.
  • Individuals interested in pursuing a career in medical device compliance.

Career path

  • Regulatory Affairs Specialist: £35,000 - £65,000 per year
  • Quality Assurance Manager: £40,000 - £80,000 per year
  • Compliance Officer: £30,000 - £60,000 per year
  • Product Safety Manager: £45,000 - £85,000 per year
  • Clinical Affairs Specialist: £35,000 - £70,000 per year
  • Medical Device Consultant: £50,000 - £100,000 per year

Questions and answers

Currently there are no Q&As for this course. Be the first to ask a question.

Certificates

Certificate of Completion (PDF)

Digital certificate - Included

Once you have successfully completed the course, you will receive a CPD Accredited PDF certificate completely free of cost as a proof of your accomplishment.

Certificate of Completion (Hard Copy)

Hard copy certificate - £9.99

Note: Delivery of hardcopy certificate is free within the United Kingdom. However, to obtain a hardcopy certificate, international students have to pay £19.99 for the shipment to their designated address.

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FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.