Quality First International

Quality First International (QFI) has established itself as one of Europe’s leading and influential consultancy companies since its founding in 1995. Specializing in the medical devices industry, QFI offers comprehensive expertise in regulatory and compliance issues, technical support, and quality management systems. The company's range of services encompasses international and national regulatory and compliance issues, development and scientific support, microbiology, EU Authorized Representation, medical device registration, and clinical trials.

QFI's extensive experience spans various technologies, including drug-device combinations, cardiovascular and minimally invasive devices, implants, TSE and animal-derived medical devices, personal protective equipment, clinical monitors, and silver-based products. Its international reach extends to clients across five continents, catering to startups, multinational corporations, and projects of varying scope.

QFI is committed to addressing clients' regulatory, technical, and compliance challenges, ensuring their medical devices can successfully navigate the global marketplace. With a focus on the European Union and North America, QFI offers a breadth of services, ranging from discrete projects to full Quality Management System implementation. Regardless of the project size or complexity, QFI leverages its wealth of experience to provide tailored solutions for its clients. Its track record speaks to its commitment to enabling clients to achieve regulatory approval and market entry swiftly and efficiently.