A study on the reprocessing and reusing of single-use devices
by Giuliana Miglierini Reprocessing and reusing are one of the key actions central to many new EU policies…
IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics
by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into…
FAT and SAT, a critical step for the introduction of new equipment
by Giuliana Miglierini There are two key moments to be faced to introduce a new piece of equipment…
The European Medicines Regulatory Network Data Standardisation Strategy
by Giuliana Miglierini The availability of interoperable data is a “must” to ensure the smooth sharing, use and…
The new guideline on combination products between medicines and medical devices
by Giuliana Miglierini The new “Guideline on quality documentation for medicinal products when used with a medical device”…