Roadmap to Market Step 1 - the EU
Roadmap to Market Step 1 - the EU
Basic Level | English | Medical Device | 35 minutes
Corresponds to ½ day of teacher-directed learning
Description
Roadmap to Market is a training in recognizing basic regulatory vocabulary and introduction to relationships between some regulatory terms & concepts that govern Medical Device manufacture within the EU and US.
There are several courses in this series, take them step by step to become more comfortable in your role as a Regulatory affairs professional.
Step 1 Roadmap to Market - EU (this course)
Step 2 Roadmap to Market - US
Step 3 Roadmap to market - Medical device QMS Introduction
Step 4 Roadmap to market - Design and development
Step 5 Roadmap to market - Medical Device Software
Step 6 Roadmap to market - Post market Surveillance
Content
- What is a Medical Device?
- What is the Intended Purpose and why is it relevant for determining the risk class of a device?
- What are Conformity Assessment Procedures?
- What is a Clinical Evaluation and what does Clinical Benefit mean?
- What is a Quality Management System and why do we need it?
- What is the Technical Documentation?
- What are critical Post-Market activities?
- Tasks and exercises are described in Course material at the bottom
Course modules
0. Introduction
Here I present myself, the purpose of the course, the goal we aim to achieve and the contents of the course.
Duration: 3 minutes (Total duration of the course: 35 minutes)1. Exercise booklet - Roadmap to market EU
Exercise booklet - Roadmap to market EU
Trainer: Faisal Kamal
Duration: 1 minute (Total duration of the course: 35 minutes)
2. What is a Medical Device?
Medical Device definition, Qualification, Classification, Conformity Assessment Procedure
Trainer: Faisal Kamal
Duration: 8 minutes (Total duration of the course: 35 minutes)
3. Purpose and Benefit go hand in hand
Introduction to Clinical Evaluation, Clinical Benefit, Risks, Intended Purpose definition
Trainer: Faisal Kamal
Duration: 5 minutes (Total duration of the course: 35 minutes)
4. Quality is KeyTry it!
Introduction to Quality Management System (QMS) requirements (Article 10)
Trainer: Faisal Kamal
Duration: 4 minutes (Total duration of the course: 35 minutes)
5. Realizing the idea requires planning
Introduction to General Safety and Performance Requirements (Annex I), General obligations and requirements, Introduction to Risk Management System requirements (Annex I)
Trainer: Faisal Kamal
Duration: 5 minutes (Total duration of the course: 35 minutes)
6. Technical File
The Technical Documentation - what is it?
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 35 minutes)
7. The product is out, but the work continues
Post-market Surveillance & Post-Market Clinical Follow-up
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 35 minutes)
8. Staying current is critical
State of the art and standards
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 35 minutes)
9. Summary
Summary of all modules
Trainer: Faisal Kamal
Duration: 3 minutes (Total duration of the course: 35 minutes)
Course material
If you want to access the additional course material for this course, you need to sign in and have access to this course.
Notes
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Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Faisal Kamal
Faisal Kamal has a master’s degree in pharmaceutical science from Copenhagen University and has worked with medical devices and regulatory affairs for more than 5 years. He is competent in the interpretation of medical device regulation (MDD, MDR) and has detailed experience with regards to medical device software (MDSW).
Faisal is trained in EN ISO 13485:2016 and has also obtained certification by SIS on internal audits in ISO 13485:2016. He has excellent skills in interpretation of regulations and a very pedagogical approach.
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The course results in a diploma that shows that you have the skills required.
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Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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