In the ever-evolving landscape of the medical device industry, ensuring product safety and efficacy is crucial for manufacturers and regulators alike. The lifecycle of a medical device doesn’t end at market entry; rather, it requires continuous monitoring...

CE Marking is not a new concept. In fact, it has been around for almost 50 years, and it's been made more important than ever with the surge in global manufacturing. Whether you are selling products in the EU or creating products for use within the 28 Mem...

Clinical noting may sound really easy yet it is not at all. There are special demands for the markings. Among these requirements is the elimination of the development of hygiene catches. Moreover, clinical marks ought to be able to stand up to passivation...

A medical device can be defined as any device that is used by human beings to diagnose and cure a disease or illness in the human body.

With the new MDR (EU) 2017/745 EU Representatives have greater responsibilities and take on significantly more risk and liabilities.

These new standards only apply to pharmaceuticals planned to deal with cancer cells in clients with late stage or advanced disease no matter the route of administration, including both small molecule and also biotechnology-derived pharmaceuticals.

In addition, when the products of its metabolism are systematically absorbed by the human body about its intended purpose, the notified body will request a scientific opinion.