Which tools should I pick from the Atlassian stack? Jira? Jira Software? Jira Core? And then there is a marketplace full of apps that sit on Jira and Confluence. Can I pick one from there or do I need apps at all? These and many similar questions are asked by almost all new Atlassian users […]
What is MDR Up-Classification and its Extension
For a number of Medical Device companies, Christmas arrived earlier in 2019. On the 17th December 2019, the second Corrigendum to the Medical Device Regulations was formally approved. This has interesting consequences for some Class I devices, that until now would have had to go through the full rigour of the MDR as of the […]
MDR: Equivalence in Clinical Evaluations
Demonstrating equivalence to an existing, marketed medical device has always been a practical way to show that a new device is safe and effective, and lengthy clinical trials are not required. Now, the “new” EU MDR introduce a new variation in the concept of “equivalence” for medical devices. Annex XIV, Part A, Clinical Evaluation lists […]
Cybersecurity in Medical Devices
As software is becoming more and more integral to Medical Devices, new opportunities arise from their networking and data exchange. But this is also exposing them to the same risks as common objects such as laptops and smartphones, i.e. unauthorized access to the device. Although the FDA “is not aware of any patient injuries or […]
How to Set Jira Notifications for Risk Management? Must-Have Tips for Risk Managers!
As you probably know by now Jira is the most customizable issue and project tracking software on the market. It is so flexible, in fact, that sometimes a simple feature might be forgotten or some things are not always easy to find. Today we will explain and provide practical tips on how to set and […]