Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a challenge, even to the most seasoned organizations. When an inspection occurs, receiving a demerit can deal a blow to an organization, not only to their regulatory standing but to the organization’s morale and reputation as well.
In our latest Whitepaper, by Gabriel Kadoo, Jr, we explore how creating a culture of quality helps to promote a quality product, while also diving into the importance of maintaining quality culture.
A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
