Introduction - A medical device's safety and assessment report is called a Clinical Evaluation Report (CER). It is based on clinical data from various device research and clinical investigations. A…

Regulatory consultants and medical device consultancies are groups of highly skilled healthcare industry experts. The medical device sector is developing ever-more-advanced equipment with the swift advancement of medical knowledge. However,…

What is the MDR (Medical Device Regulation) in Europe? For medical device firms that want to sell their products in the European market, compliance with the European Medical Device Regulation…

Introduction: The journey to bring a medical device to market in the United States is a complex and highly regulated process that necessitates meticulous planning, thorough documentation, and adherence to…

Introduction: For several manufacturers of medical devices, access to international markets is crucial. As technology evolves quickly, obtaining marketing authorizations is essential, especially for new and novel devices. Gaining development…

Overview: With the initial goal of averting another European war, the European Union (EU) was established in 1993 following several treaties dating back to the 1950s. This geopolitical entity was…

Introduction: The development and distribution of medical devices play a crucial role in advancing healthcare and improving patients' lives. However, before a medical device can reach the market, it must…

Introduction: Protecting and promoting the general public's health and safety, including healthcare provision, is one of the government's fundamental duties. A functioning healthcare system requires readily available, reasonably priced, safe,…