Skip to content

Essential Components of European Medical Device Regulations

CPD Accredited ! Free Certification | FREE Retake Exam | Lifetime Access | No Hidden Fees


Online Training Academy

Summary

Price
£12 inc VAT
Study method
Online, On Demand What's this?
Duration
1.8 hours · Self-paced
Qualification
No formal qualification
CPD
10 CPD hours / points
Certificates
  • Digital certificate - Free
  • Reed Courses Certificate of Completion - Free
Additional info
  • Tutor is available to students

Add to basket or enquire

Overview

Unlock the secrets to navigating the intricate landscape of European medical device regulations with our comprehensive course. Designed for those who seek mastery in understanding and applying the latest EU standards, this course is your gateway to compliance excellence. Dive deep into the regulatory environment, where you’ll explore the essential components that govern the medical device industry in Europe. Learn how to seamlessly integrate these regulations into your practice, ensuring your products meet the highest standards of safety and efficacy.

Key Features:

  • CPD Certified
  • Free Certificate from Reed
  • CIQ Approved
  • Developed by Specialist
  • Lifetime Access

Certificates

Digital certificate

Digital certificate - Included

Reed Courses Certificate of Completion

Digital certificate - Included

Will be downloadable when all lectures have been completed.

CPD

10 CPD hours / points
Accredited by CPD Quality Standards

Curriculum

1
section
5
lectures
1h 46m
total
    • 1: Module 01: Overview to European Regulations on Medical Devices 33:17
    • 2: Module 02: Essential Components of EU MDR 29:12
    • 3: Module 03: Reporting Requirements and Identification 16:21
    • 4: Module 04: Quality System in Medical Device Regulation 25:17
    • 5: CPD Certificate - Free 01:00 PDF

Course media

Description

Discover the nuances of reporting requirements and identification processes, critical for maintaining transparency and accountability. Our expertly curated content guides you through establishing a robust quality system, pivotal for regulatory success. Equip yourself with the knowledge to confidently manage regulatory submissions and navigate quality audits with ease. Join a community of like-minded professionals and elevate your regulatory expertise, ensuring your organisation stays ahead in the competitive medical device market. Enrol now to transform your approach to European medical device regulations and lead with confidence in a compliant and efficient manner.

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

Learning Outcomes:

  • Understand the core elements of European medical device regulations.
  • Identify key components of EU Medical Device Regulation (MDR).
  • Master reporting requirements and device identification processes.
  • Implement quality systems in medical device regulation.
  • Analyse essential EU MDR regulatory requirements.
  • Navigate the complexities of EU medical device compliance.

Who is this course for?

  • Regulatory affairs specialists in the medical device industry.
  • Quality assurance professionals in healthcare.
  • Compliance officers in medical device companies.
  • Medical device product managers.
  • Legal advisors in healthcare regulation.

Career path

  • Regulatory Affairs Specialist
  • Quality Assurance Manager
  • Compliance Officer
  • Medical Device Consultant
  • Product Manager
  • Regulatory Affairs Associate

Questions and answers

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

Reviews

Currently there are no reviews for this course. Be the first to leave a review.

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.