We assist medical device manufacturers in navigating the FDA process to gain approval through De Novo classification for novel, low-to-moderate-risk devices without a predicate, ensuring compliance and a smoother path to market entry.
De Novo classification pathway is one of the faster ways in which medical devices that have no predicate or are new can be authorized for marketing by the FDA. Manufacturers can use it to acquire marketing authorization by the FDA on devices that have a moderate to low risk but fall under a new classification.
Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.
