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
- Certificate of completion - Free
- Exam(s) / assessment(s) is included in price
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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.
CPD
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
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.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.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
This was helpful.
Certificates
Certificate of completion
Digital certificate - Included
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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.
