Digital Health Devices : Challenges for Regulatory Compliance
Digital Health Devices raised a lot of attention to the MedDevice community for the challenges that need to be addressed…
Artificial Intelligence and Machine Learning as Medical Device Software
Artificial Intelligence for Medical Device: new challenges for regulatory compliance.
Eudamed Database for Medical Devices in Europe: EU MDR requirements
Eudamed is a database that will be used to monitor both the safety and performance of medical devices distributed in…
Statistic for Quality Management Systems: ISO and FDA Requirements
The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and…
ISO 20417 : New ISO Standard on Information to be Provided by Manufacturer
A new standard is expected to be published in early 2021: it is named ISO 20417 Medical devices — Information…
New ISO 14971: Updates for Risk Management
ISO 14971 for medical device risk management was approved in December 2019. Although no significant changes on the risk management…