Roadmap to Market Step 2 - US and the FDA
Roadmap to Market Step 2 - US and the FDA
Basic Level | English | Medical Device | 31 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
Step 2 Roadmap to Market - US (this course)
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
- Similarities and differences in definition, US vs EU?
- Introduction Regulatory process for Medical Devices in the US
- Risk classification and risk-based regulatory pathways
- Build in quality during development and document it in Design History File
- When FDA requires Post-Market Surveillance
- Introduction to useful resources on FDA website
- Tasks and exercises are described in Course material at the bottom
Course modules
0. Introduction
Here we introduce the fact that things are similar but not identical in the US compared to the EU.
Duration: 2 minutes (Total duration of the course: 31 minutes)1. Exercise booklet - Roadmap to market US and the FDA
A brief explanation how to work with the exercises and the booklet.
Trainer: Faisal Kamal
Duration: 1 minute (Total duration of the course: 31 minutes)
2. What is a Medical Device?
Medical Device definition – comparison US to EU. Classification. How the US FDA regulates Medical devices. Different pathways to the US market. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.
Trainer: Faisal Kamal
Duration: 10 minutes (Total duration of the course: 31 minutes)
3. MMAs, SaMD & Accessories
How Mobile Medical Apps and Software as a Medical Device are regulated. Introduction to the concept of accessories.
Trainer: Faisal Kamal
Duration: 5 minutes (Total duration of the course: 31 minutes)
4. Quality is always KeyTry it!
Introduction to 21 CFR 820, Quality System Regulation/CGMP for Medical devices. Quality is built in during design and development. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)
5. Controlling the outcome
How regulatory requirements are differentiated depending on risk. Different regulatory pathways for different risk classes. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)
6. Design History File
The importance of documenting the development activities. When FDA require Design controls and when exemptions apply. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)
7. The product is out, but the work continues
FDA perspective on Post-market Surveillance.
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 minutes)
8. Staying current is critical
FDA concept of Recognized Consensus Standards. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.
Trainer: Faisal Kamal
Duration: 3 minutes (Total duration of the course: 31 minutes)
9. Summary
Summary of the course. Understanding why definitions and reading requirements in detail is important. After this section, there is an extra task described in the booklet. The task will be included in the questions to verify your knowledge.
Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 31 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
If you want to save your notes for this course, you first need to purchase it and be signed in.
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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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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