A professionally developed, interactive and engaging online training course.
Delivering unique, exciting and interactive e-learning technology courses.
ABOUT THE COURSE
This is a professionally developed Medical Device training course which incorporates the Medical Devices Regulation (MDR) implemented in June 2017 with compliance by 2021, along with ISO 14155:2020 and Regulatory guidance from the FDA and MHRA. The Medical Devices Regulation (MDR) supersedes the previous Medical Devices Directive (MDD).
This highly interactive and engaging course enables the learner to develop knowledge and understanding of the Medical Device development process and how to remain compliant with all the relevant Regulations, Guidelines and Standards to gain marketing approval.
It is suitable for anyone currently working on Medical Device Clinical Investigations or those wishing to develop their knowledge, skills and understanding of Medical Devices and how to be compliant with the Regulations, Guidelines and Standards that govern their development
Finally, an online learning platform that’s fun, engaging and can be taken on any device, anywhere, anytime.
WlLL THE COURSE TAKE?
This course takes approx. 2-3 hrs to complete. This time will vary depending on the user’s previous knowledge, and as the course contains lots of links to more information, it will also depend how many the user chooses to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
Module 1 - What is Medical Devices?
- What is a Medical Device?
- Device classification
- Medical Device Regulators
- Introduction to Regulations, Guidelines and Standards
Module 2 - Medical Device Regulation
- Medical Device Regulation (MDR)
- How is MDR different from MDD?
- Practical implications of MDR for Sponsors
Module 3 - ISO 14155:2020
ISO 14155:2020:- GCP principles, Informed Consent, Clinical Investigation Planning, structure and content of the Clinical Investigation Plan (CIP), Monitoring Plan, Clinical Investigation conduct, electronic data systems, protecting Medical Devices from cyber-attack, Sponsor, Investigator and Monitor responsibilities, communicating with Ethics Committees and ethical considerations
Module 4 - Gaining Device Approval
- Gaining Device Approval
- Investigational Device Exemption (IDE)
- CE Marking
Module 4 - Course Summary
- Course Summary
- Testy Your Understanding Scenarios
- Test Your Knowledge – Course Exam
Ewelina Testoni, PhD
Fiona Duthie, PhD
Stefan Smet, Writingale
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0161 633 4594
82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT