How To Create a QMS in Sharepoint: Complete Guide + Don’t Do It
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
As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?
We want to bring MDR class I software as a medical device to market. We’ve talked to other founders and...
July 26, 2022
Do We Need a User Manual for Our Software as a Medical Device?
We’re developing a mobile app which will be a medical device. We’re wondering whether we have to provide a user...
November 5, 2021
Should We Develop Our Software Or Set Up Our QMS First?
We’ve just started developing software which will be a medical device. Some consultants now told us that it’s important to...
September 1, 2021