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 Europe and it has been introduced in parallel with the
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 FDA regulation have specific requirements. This is done to ensure
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 to be supplied by the manufacturer and it will
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 process was defined, a substantial re-organization of the standard was performed.