Roadmap to market Step 3 - Medical Device QMS Introduction

Roadmap to market Step 3 - Medical Device QMS Introduction

Basic Level | Course | 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.

1.      Step 1 Roadmap to Market - EU

2.      Step 2 Roadmap to Market - US

3.      Step 3 Roadmap to market - Medical device QMS Introduction (this course)

4.      Step 4 Roadmap to market - Design and development (will be launched shortly)

5.      Step 5 Roadmap to market - Software as a Medical device (will be launched autumn 2021)

6.      Step 6 Roadmap to market - Post market Surveillance (will be launched autumn 2021)

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

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Training organisation

The course results in a diploma that shows that you have the skills required.


All prices shown exclude VAT.


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