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Medical Devices Including 2020 ISO updates

Examine what Medical Devices are, who regulates them and how to comply with Regulations, Guidelines and Standards.

Trainingonline4U Ltd

Summary

Price
£300 inc VAT
Or £50.00/mo. for 6 months...
Study method
Online
Duration
6 hours · Self-paced
Access to content
90 days
Qualification
No formal qualification
CPD
6 CPD hours / points
CPD What's this?
Certificates
  • Certificate of completion - Free
Additional info
  • Exam(s) / assessment(s) is included in price
2 students purchased this course

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Overview

This is a professionally developed, highly engaging and interactive Medical Device training course that incorporates the Medical Devices Regulation (MDR) implemented in June 2017, along with ISO 14155 updated for 2020 and Regulatory guidance from the FDA and MHRA.

The Medical Devices Regulation (MDR), supersedes the previous Medical Devices Directive (MDD).

This course examines how to ensure compliance with Regulations, Guidance and Standards through the full Medical Device development process, from devising Clinical Investigation plans to gaining marketing approval.

This course will enable you to:

  • Become familiar with the regulatory requirements governing clinical trials involving Medical Devices.
  • Understand the role of clinical studies in the development of Medical Devices.
  • Develop in depth knowledge and understanding of the content and structure of the Medical Device Regulation and ISO 14155:2020
  • Understand the responsibilities of each of the Medical Device Clinical Investigation stakeholders in light of ISO 14155:2020 and consider practical implementations of these Guidelines, Standards and Regulations.

Certificates

Certificate of completion

Digital certificate - Included

CPD

6 CPD hours / points
Accredited by The CPD Certification Service

Course media

Description

This is a modular course, which guides the learner through the complex Guidelines, Standards and Regulations governing the development and marketing of Medical Devices.

Module 1

What is a Medical Device?

Device Classification

Defining Risk inMedical Devices

What is a CE mark?

Module 2

Regulatory, Advisory and Notified Bodies

Regulations, Guidelines and Standards

ISO 14155:2020: Key Players

Module 3

Clinical Investigation Planning

Safety Reporting

Clinical Evaluation Plan and Clinical Evaluation Reports

Electronic Data Systems

Roles and Responsibilities

Module 4

Informed Consent

Marketing a Device in the U.S.

Protecting Medical Devices from Cyber Attacks

Module 5

Course Summary

Test Your Knowledge - Course Exam

Who is this course for?

This course is suitable for anyone working in or wishing to work within the Medical Device industry.

Career path

Clinical Research Nurse, Sponsor, Investigator or Monitor on a Medical Device Clinical Investigation.

Questions and answers

No questions or answers found containing ''.

Keeran asked:

Please could you send a leaflet to my email for further review please.

Answer:

Hi Keeran, I wondered if you had managed to look at the leaflet I sent you and if you were still interested in this course. We have a current offer on for 20% off any clinical course from our website if you enter code Clinical20

This was helpful. Thank you for your feedback.
Keeran asked:

Hi Linda, Thanks for the reply. If i don't work within the clinical trial sector but aiming to take that step into the sector is this aimed at that

Answer:

Hi It will certainly help you gain more information and give you a course to add to your CV. I would recommend our Clinical Professionals course though if you want a broader overview of clinical research. I also offer a full support package for those wanting help and support getting their first clinical research role. I will send you more information on this also tomorrow. Hope this helps.

This was helpful. Thank you for your feedback.
Keeran asked:

Hi, Can you confirm who can start this course? Do i need any formal qualification to do to course? Is the qualification nationally recognised?

Answer:

Hi Keenan, Thanks for you enquiry. This course is aimed for anyone working within clinical research on medical devices. You do not need any qualifications to take our course. The course is a recognised accredited course which we have created to be interactive and engaging whilst delivering detailed content and a certificate upon completion. I can also send you a leaflet about the course if you would like. Many thanks Linda Director Trainingonline4 u

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Legal information

This course is advertised on Reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

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.
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