Roadmap to Market Step 3 - Medical Device QMS Introduction
Roadmap to Market Step 3 - Medical Device QMS Introduction
Basic Level | English | Medical Device | 1 hour and 3 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
Step 3 Roadmap to market - Medical device QMS Introduction (this course)
Step 4 Roadmap to market - Design and development
Step 5 Roadmap to market - Medical Device Software
Step 6 Roadmap to market - Post market Surveillance
With this training (Step 3) you will get a first insight in the regulatory landscape that surrounds Quality management Systems for Medical Devices. It covers mainly European and US requirements but gives a brief description of other International activities in the regulatory area.
Content
- What is a medical device and why is it different to other products
- How are medical devices classified
- Regulatory requirements on medical devices
- How to get a medical device to the market
- How does it impact daily tasks in a MD company
- Brief overview of ISO 13485
- Where can you find out more
Course modules
1. Introduction
Presentation of the training, Anna Lundén and Key2Compliance.
Trainer: Anna Lundén
Duration: 2 minutes (Total duration of the course: 1 hour and 3 minutes)
2. What is a medical device and why is it different to other products?
To understand what medical device is, how it differs from drugs and what and IVD medical device is.
Trainer: Anna Lundén
Duration: 3 minutes (Total duration of the course: 1 hour and 3 minutes)
3. Classification of medical devices
To understand on a high level the risk classification and see some examples from different classes.
Trainer: Anna Lundén
Duration: 3 minutes (Total duration of the course: 1 hour and 3 minutes)
4. Regulatory requirements on medical devices
Brief description of EU and US model.
Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 1 hour and 3 minutes)
5. How to get a medical device to the market
To understand about CE marking in Europe and the equivalent in the US.
Trainer: Anna Lundén
Duration: 5 minutes (Total duration of the course: 1 hour and 3 minutes)
6. Quality system requirements
How a quality management system both is a requirement and contributes to the ability to fulfil legal requirements, but also is good for patient protection and for the business.
Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 1 hour and 3 minutes)
7. Impact on daily tasks
Understand that daily tasks are affected by procedures and that these procedures are written to make sure legal requirements are fulfilled.
Trainer: Anna Lundén
Duration: 4 minutes (Total duration of the course: 1 hour and 3 minutes)
8. Highlights of ISO 13485
General overview of the standard and why documents and records are so important for traceability.
Trainer: Anna Lundén
Duration: 5 minutes (Total duration of the course: 1 hour and 3 minutes)
9. Highlights of ISO 13485
Overview of management controls and the role of top management as per Chapter 5.
Trainer: Anna Lundén
Duration: 3 minutes (Total duration of the course: 1 hour and 3 minutes)
10. Highlights of ISO 13485
Overview of resources as per Chapter 6.
Trainer: Anna Lundén
Duration: 5 minutes (Total duration of the course: 1 hour and 3 minutes)
11. Highlights of ISO 13485
Overview of product realization as per Chapter 7.
Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 1 hour and 3 minutes)
12. Highlights of ISO 13485
Overview of measurement, analysis and improvement as per Chapter 8.
Trainer: Anna Lundén
Duration: 10 minutes (Total duration of the course: 1 hour and 3 minutes)
13. Summary
A summary and key take aways.
Trainer: Anna Lundén
Duration: 2 minutes (Total duration of the course: 1 hour and 3 minutes)
Course material
There is no additional course material for 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
Anna Lundén
Anna Lundén is one of the founders of Key2Compliance® and works in close contact with the Life Science industry with both training and consultancy. She has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with both EU and FDA requirements and expectations.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
Save time
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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