TGA’s Approach for Regulation of Direct to Consumer Digital Medical Devices
Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view;…
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity…
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
The European Database on Medical Devices (EUDAMED) is an IT system developed by the European Commission to enhance the transparency,…
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…