Articles tagged with: Technical guide

The use of equivalent spare parts not produced by the original device manufacturer is acceptable. Rules for manufacturers.

The clear definition of useful life and its various interpretations for each type of device (active, software, single-use, implantable...)

Guidelines for UDI affixing process verification and validation obligations and our complete and compliant printing system.

We share the high-level scheme applied to our clients: the most straightforward approach to post-market surveillance.

All the details regarding the UDI code for medical devices, issuing bodies, and methods of obtaining and applying.

All the steps to independently register UDI codes of medical devices in Eudamed, the European database.

All the steps to independently register an economic operator in Eudamed, the medical device database.