The distinction between medical devices and drugs may seem clear, but there are areas of intersection where boundaries become blurred. Products such as drug delivery systems, which combine both aspects, require a deep understanding of the regulations for both categories. This short guide will explore these...

Regulatory writing is not a static competence. As regulations, technologies and market needs evolve, it is vital that regulatory writing experts stay up to date, as investing in continuous training not only ensures compliance, but can also open up new opportunities for companies in the medical...

The launch of medical devices in Italy is not limited to compliance with Italian regulations. Given that Italy is a member of the European Union, companies must also consider the European regulatory framework. An essential component of this framework is the European Medical Device Vigilance System. Here’s an...

Regulatory writing is one of the most delicate and crucial aspects in the launch of new medical devices and drugs. A mistake, even a small one, in this area can lead to significant delays, additional costs and, in the worst case, the failure to launch a product on the market. If we consider the huge...

Every year, medical innovation leads to the launch of new devices aimed at improving and saving lives. However, before these products can reach the Italian market, they must go through a rigorous approval process. This path, although complex, is essential to ensure the safety and effectiveness of the devices....

In the complex world of medical devices and drugs, regulatory writing emerges as an essential component, especially in Italy. This area interacts at various levels with legislation, from the local to the European and, in some cases, the international one. Knowing how to navigate this intricate web of...

On 17 September, the World Patient Safety Day was celebrated, an initiative promoted by the World Health Organization (WHO) aimed at raising public and professional awareness of the importance of patient safety in the health system. This year’s theme wanted to underline the fundamental value of inclusion and...