Regulatory

Drug-device combination (DDC) products are increasingly demonstrating the value they bring in diagnosing, treating, and curing complex diseases. The growth of the DDC market is driven by several factors including an increase in chronic diseases, a well-established medical technology industry, a rise in surgical procedures, the availability of funding for research and innovation etc. As […]

Currently, there are over 2 million diverse types of medical devices accessible in the global market, which are further classified into more than 7000 generic device groups. As of 2021, the worldwide medical devices market was valued at USD 488.98 billion and is predicted to grow at a compound annual growth rate (CAGR) of 5.5%

Introduction The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve

Technological disruptors are gradually revolutionizing various aspects of life sciences and healthcare. Software is slowly becoming an important part of products and are being integrated into digital platforms for medical and non-medical purposes. There are 3 types of software-related medical devices: 1) Software as a medical device (SaMD), 2) software in a medical device, and

Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European