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The responsibilities of a clinical investigation sponsor

The responsibilities of a clinical investigation sponsor

Jan 17, 2023 | Articles, Clinical investigation ISO 14155 | 0 comments

This article covers the responsibilities of the sponsor – one of the most important stakeholders in a clinical investigation.  If you want to know more about sponsor responsibilities, have a look at the video below from the course Introduction to Clinical...
How to create a medical device work breakdown structure

How to create a medical device work breakdown structure

Jan 11, 2023 | Articles, Medical device project management | 0 comments

A work breakdown structure is a very useful tool for any project manager, yet many do not know what it is. This article provides an overview of how a medical device work breakdown is created.  If you would like to know more about creating a work breakdown structure...
What the EU MDR PMS plan must include 

What the EU MDR PMS plan must include 

Dec 15, 2022 | Articles, Medical device regulation | 0 comments

To achieve the purpose of the manufacturer’s PMS system, the manufacturer must have a PMS plan. This is also stated in Article 84 of the MDR. But article 84 basically only references Annex III, which is the annex that describes the requirements on the technical...
Project management in the medical device industry

Project management in the medical device industry

Nov 21, 2022 | Articles, Medical device project management | 0 comments

What is project management for product development of medical devices? And most importantly, why should you be working with project management in the medical device industry? In this article, you will find the basic principles and practices of project management with...
Reporting post-market surveillance activities 

Reporting post-market surveillance activities 

Nov 4, 2022 | Articles, Medical device regulation | 0 comments

Post-market surveillance reporting requirements are different depending on the classification of the devices the PMS system is covering. This article provides an overview of PMS reporting according to medical device classification.  PMS reporting for class I medical...
Post-market surveillance as a medical device requirement in the EU

Post-market surveillance as a medical device requirement in the EU

Oct 24, 2022 | Articles, Medical device regulation | 0 comments

Dealing with post-market surveillance, or PMS, is a very important part of having medical devices on the EU market. It is also one of the focus areas of the notified bodies. This makes it essential for all manufacturers and others working within the medical device...
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Medical Device HQ

Medical Device HQ
In-house training, public and online courses on managing and developing safe medical devices

Recent Posts

  • The responsibilities of a clinical investigation sponsor
  • How to create a medical device work breakdown structure
  • What the EU MDR PMS plan must include 
  • Project management in the medical device industry
  • Reporting post-market surveillance activities 

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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

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Gantus AB, Björkvägen 14, SE-224 56 LUND, Sweden,
Corporate ID: 556736-4541,
VAT No: SE556736454101,
Location: Malmö, Sweden

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Recent Posts

  • The responsibilities of a clinical investigation sponsor
  • How to create a medical device work breakdown structure
  • What the EU MDR PMS plan must include 
  • Project management in the medical device industry
  • Reporting post-market surveillance activities 
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