Elevate your Quality Assurance and Regulatory Affairs with our help: Technical Documentation Management Compiling, reviewing, and updating technical files for medical devices, medical device software, and in vitro diagnostic devices to ensure full regulatory...
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 include Clinical Evaluation Plan (CEP) Development We create a detailed CEP that outlines the strategy and methodology for your device’s clinical evaluation. This plan defines the scope of clinical data to gather (such as...
Our CE-Mark Services Include: Document Structure Setup We set up a structured document system for your Technical File, considering product-specific requirements and ensuring that every Technical Document is organized for efficient review. Prefilled Technical File...
KEY ASPECTS OF OUR MARKET ANALYSIS SERVICES Market Understanding We deliver detailed insight into your target medical device market—including segmentation, unmet needs, and regional dynamics—giving you a clear understanding of where and how your product fits....
