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 […]

Read more ››

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 […]

Read more ››

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 […]

Read more ››

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 […]

Read more ››

How SoftComply eQMS helped speed up the CE-marking of munevo DRIVE – a Case Study

“If you are developing medical device software and need to go through the certification process, look what SoftComply has to offer!”, says Claudiu, the co-founder and CEO of Munevo. Munevo is the company behind munevo DRIVE – the first wheelchair control system that uses smart glasses enabling people to become more independent and safely drive […]

Read more ››