Published: 2019/01/08 - Guidance - by Cord Schloetelburg
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.
Software Classification: Insights in EU Guidance
The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!
Usability Engineering: Regulatory Requirements and Product Optimization
Use and user errors are critical risks of medical devices. Learn in our workshop how to set up an efficient usability engineering.
Improving Patient Compliance With Speech Recognition
The use of patient diaries for telemonitoring often fails due to a lack of compliance. The use of speech recognition can increase patient compliance.
Published: 2019/06/13 - Guidance - by Thorsten Prinz
[Video] How to Achieve MDR Compliance for Medical Apps
It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.
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!
In-Clinic Workshop “Emergency Medicine”
In our workshop you learn from physicians what is needed for successfully developing medical devices for emergency medicine and radiology.
Clinical Evaluation of Medical Devices
Learn in our workshop how to be compliant with the MEDDEV guideline and MDR requirements for clinical evaluation of your medical device.
Trade Secrets: Protect Your Intellectual Property
You must understand the importance of protecting your trade secrets or the development of your medical software was useless!