Miscellaneous

Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start that new Clinical Evaluation Report (CER) project for Europe, or remediate your current documents based on Notified Body feedback... and [...]

Are you shopping for CER writers? Or perhaps trying to evaluate if this is the type of document you can make work yourself? [...]

So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing the technical file. One of the more common tasks is taking a look [...]

Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen. Off-label use, installation/service issues, lack of training, and many other causes can lead [...]

The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in the European Union. For manufacturers of higher-risk devices (Class IIa, Class IIb, and [...]

The whole point of medical devices is to improve patient safety and patient quality of life. That's it, that's the gist.   To do that, medical devices need to work, and they need to be [...]

The MEDDEV 2.7.1 is the most important technical guidance document for literature search under the MDR in the medical device regulatory industry. Since the MDCG documents do not currently offer any concrete guidance on [...]

A global safety monitoring system with automated data collection. Helps detect signals, manage events, and generate regulator-ready reports

A global safety monitoring system with automated data collection. Helps detect signals, manage events, and generate regulator-ready reports

A global safety monitoring system with automated data collection. Helps detect signals, manage events, and generate regulator-ready reports

A global safety monitoring system with automated data collection. Helps detect signals, manage events, and generate regulator-ready reports

A global safety monitoring system with automated data collection. Helps detect signals, manage events, and generate regulator-ready reports