Greystone provides interactive tools for medical device decision makers. These tools are designed and created to support the rapid and intuitive acquisition and visualization of large and complex data sets for decision support. The tools we provide address limitations to the currently available methods for accessing industry data. In the practical sense, our tools essentially unlock the value of existing data and information sources, assisting medical device professionals in meeting and exceeding their professional and organizational objectives.
Establishment Registration and Device Listing
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration. The FDA Establishment Registration and Device Listing database contains detailed information on the medical device activities of over 31,000 entities from 96 countries.
Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments, and/or supporting activities such as specification development, contract sterilization and re-manufacturing. It’s also a powerful resource for companies seeking to find partners and/or outsourcing projects to support their in-house medical device franchise. Because the data on all listed entities is updated annually, this data source is self-renewing, providing users access to a comprehensive listing of medical device and service providers that reflects current market conditions.
While it represents a powerful source of answers to common medical device sourcing questions, the sheer number of entries and data set options available in the database limit access to the full value of the underlying data for the average user. Using the online form at accessdata.fda.gov is tedious and self-limiting, making its utility as a first line data access method impractical. Realizing this, Greystone created a fully searchable version of the FDA Establishment Registration and Device Listing database.
We’ve built a user friendly interface that allows industry professionals to parse, collate and aggregate medical device information across geographic locations (cities, states, provinces, countries), device applications (e.g., cardiovascular, ENT, orthopedics, surgery, etc.), product codes, suppliers, and establishment services (e.g., contract manufacturing, re-packagers, specifiers, etc.). This information tool – TotalVision© – allows users to search the 41,000 rows in the database across thirteen tables and eight searchable dimensions and return precise data sets and information by filtering the data, in a matter of seconds. For more information on TotalVision©, please reach out to us by using the form below.
TotalVision© – Interactive Tools for Medical Device Decision Makers