What is a GS1? Shedding light on the UDI provider

What is GS1? And how do we get GS1 UDIs?...
August 9, 2023

What is IFA?

What is IFA? And what does it have to do with UDIs?...
August 9, 2023

What’s the Difference Between a Document and a Record?

What the hell is the difference between a document and a record?...
June 22, 2023

How Can We Set Up a QMS in Sharepoint?

We’re already using Microsoft software for our company, like Teams and Office. Now need to set up a Quality Management...
June 20, 2023

Should We Choose Our Cloud Provider Based on Free Credits?

Our startup is part of an incubator and we’ve been approached by a cloud provider which offered us a few...
May 30, 2023

QMS Software And Jira / GitHub / GitLab Integrations: Don’t Make a Mistake!

We’re looking for QMS software. It’s important for us that it has a Jira / GitHub / GitLab integration because...
May 24, 2023

Do We Need AI / Machine Learning Consultants?

We want to develop a medical device which is based on an AI model. We’ve recently been approached by consultants...
May 24, 2023

Can We Bring a Lifestyle Device to Market First?

We’re developing software as a medical device which might be class I or IIa under the MDR. Right now, we...
May 24, 2023

Should You Do a BfArM Classification Request? The Answer Is No.

We have no clue how to classify our medical device under the MDR. It could be class I, so we...
November 15, 2022

How Can We Set Up a QMS in Confluence / Jira?

We’re already using Confluence and Jira for our development planning. Now we need to set up a Quality Management System...
July 28, 2022

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