What Do Software Validation Services Entail?

During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in your company being issued a 483. If a computer system is used to provide information to a regulatory body (such as under FDA 21 CFR Part 11), or meet requirements for the regulatory body, the system must be validated. Continue reading

Medical Device Labeling Guidelines

Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff.

The FDA’s final rule has established a system for the unique identification of medical devices that is based on their use and means of distribution. As the system becomes fully implemented, device labels will carry a unique device identifier (UDI). Companies responsible for device labelling are also required to submit certain information pertaining to each device to the FDA’s Global Unique Device Identification Database (GUDID) so that the public can search for and download this information. Continue reading

Posted in UDI

Understanding the FDA UDI Final Rule

The U.S. Food and Drug Administration (FDA) released the final rule on a Unique Device Identifier (UDI) system on September 20, 2013. The system, along with the Global Unique Device Identification Database (GUDID) was 10 years in the making and is a vital step toward increasing the safety of medical devices. One of the most significant changes is the elimination of the requirement that all implantable medical devices—such as pacemakers and heart valves—have the UDI printed on the device itself. Originally the proposed rule required manufacturers to mark the UDI directly onto the following types of  devices: Continue reading

Posted in UDI