This package is designed to help start-ups build a strong and secure quality management system (QMS) tailored to your business needs. The ISO 13485 Starter Kit is built to ensure your QMS meets your regulatory requirements for certification as this standard defines a QMS as the basis for compliance in the development, manufacturing and trade of medical devices. Developed using the full scope of our in-depth expertise and longstanding experience, the ISO 13485 Starter Kit is the fastest and most direct route to building an effective and efficient QMS. This package includes a 2-hour consultation call, 4-hour on-site workshop, 2-hour training session and a 4-hour mock audit, to give you both a secure system and fully trained team for audit readiness. For clients accessing the European market we will integrate QMS requirements under the EU’s MDR / IVDR free of charge.