KEY ASPECTS OF FDA APPROVAL PROCESS SERVICES 510(k) Clearance (Premarket Notification) The 510(k) process involves submitting a device to the FDA to determine if it is substantially equivalent to a legally marketed device that is not subject to Premarket Approval...
OUR COMPREHENSIVE CER SERVICES In-Depth Clinical Evaluations We conduct thorough clinical evaluations of medical devices. This includes a comprehensive review of clinical data, whether from clinical investigations of your device or studies on substantially equivalent...
OUR SERVICES INCLUDE Document Structure Setup We set up a structured document system for the technical file, considering product-specific requirements. Prefilled Technical File Templates Our prefilled document templates are in accordance with MDR 2017/745 and relevant...
KEY ASPECTS OF OUR MARKET ANALYSIS SERVICES Market Understanding We provide insights into the medical device market, helping companies understand the dynamics, trends, and key players in the industry. Competitive Landscape Analysis Our services include a thorough...
KEY ASPECTS OF OUR MEDICAL DEVICE DUE DILIGENCE SERVICES Intended Use Evaluation We evaluate the intended use of the device, ensuring it meets an unmet need and considering its potential for multiple applications. This includes assessing the likelihood of healthcare...
