The American Food and Drug Administration (FDA), the European Community and other governments set stringent requirements for medical devices (MD), in vitro diagnostics (IVD) and combination products (CP). Demonstrating that your product complies with regulatory is the biggest challenge for healthcare manufacturers.
Synergio’s Cockpit application implements a Quality Management System in line with the FDA guidelines called Design Controls. Cockpit supports the entire design process from Intended Use to Product Validation. As a result, your Design History File (DHF) is populated during the design process, enabling you to demonstrate your product is compliant and ready for the market.