Owing to their reliance on external energy sources, active medical devices pose moderate risk to the patients and users. Hence, they have to be regulated accordingly. They fall under the purview of FDA 510(k). Manufacturers will have to demonstrate their device is...
Similar to other medical devices, SaMDs will also have to comply with US FDA regulations to be launched in US. Navigating the US FDA regulations for SaMDs can be a daunting task. Hiring an US FDA 510(k) consultant for SaMD can streamline the application process. What...
India’s laser hair removal industry is booming at an unprecedented rate. Growth of the grooming industry, rising awareness of aesthetic treatments, and technological advancements are all driving the growth. CDSCO regulates the laser hair removal and skin laser...
Are you a medical device manufacturer seeking FDA 510(k) clearance? Well, you have landed in the right place. We are a renowned US FDA 510(k) consultant. Our team will help you navigate the FDA’s regulatory requirements with ease. Our aim is to reduce the time to...
US FDA 510(k) submission is a premarket notification required for medical devices intended for U.S. market entry. This pathway is essential for devices that are not exempt from FDA 510(K) and is not already legally marketed. Additionally, it is required for devices...