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Unindustria

Di Renzo Regulatory Affairs is part of Unindustria

Di Renzo Regulatory Affairs has become a member of Unindustria, a regional association that is part of the system of...

Sante DI Renzo

What are the regulatory affairs today?

It is a lesson from great masters that the more you know a subject the easier you will be able...

Ricerca scientifica per Farmaci Orfani

What are orphan drugs?

What are orphan drugs? Why are they important? Is there any incentive for their development? Orphan drugs are medicines developed...

Quality Management System for medical devices/in vitro diagnostics (DM/IVD)

The Quality Management System (QMS) is a control system, i.e. a set of activities aimed at verifying that the outcomes...

Payback e decreto bollette

Pay-back for MDs, new developments from the “Decreto Bollette”

The so-called “Bills Decree” (“Decreto Bollette” – Law-Decree 30 March 2023, no. 34 “Urgent measures to support families and enterprises...

Intelligenza Artificiale

Artificial Intelligence in medical devices: challenges and opportunities

The sector of Artificial Intelligence (AI) is continuously evolving, and in the next few years the impact of this new...

Time extension of the MDR and IVDR transitory period

On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 was...

Le traduzioni giurate

Sworn translations. How, where, when

In an increasingly globalised world – where transactions, performances and services mostly occur at international level – sworn translations have...

Food for Special Medical Purposes

Food for Special Medical Purposes (FSMP) is a very particular category of products, for people with specific food/nutritional difficulties. From...