Medical Device QMS Introduction

Medical Device QMS Introduction

Basic Level | Course | English | Medical Device | 1 hour and 3 minutes

Corresponds to ½ day of teacher-directed learning

Description

With this training you will get a first insight in the regulatory landscape that surrounds 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)

Additional material

There is no additional 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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