Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example! Read more
Tag: EU MDR
Cyber Security Threats in Healthcare
Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management. Read more
Stand-Alone Software as Medical Device
Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own. Read more
Medical Device Classification: The Software Special
The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes. Read more
EU MDR Factsheet for Manufacturers of Medical Devices
Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going. Read more
Transition Period of the EU MDR: What Dates Manufacturers Need to Know
The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period. Read more
Delegated Acts and Implementing Acts
Delegated acts and implementing acts are instruments of the European Commission to ensure the implementation of the EU MDR. Read more
Medical Device Certification Based on the New EU MDR: a Step by Step Guide
Medical device certification is a prerequisite for market access in Europe. Use this checklist to start certification based on the new EU MDR. Read more
