To Be Successful with FDA Investigational Device Exemptions
To be successful in any phase of the development and testing of a medical device, a company must have integrated solutions for CAPA, training, customer complaints, and nonconformances according to FDA IDE. An automated system for document control and document management (see information on MasterControl Documents) is equally important. This ensures the integrity of a company's documents and processes.
How MasterControl Helps with FDA IDE
MasterControl, a leading provider of software for regulated companies, offers configurable, easy-to-use integrated software applications. These solutions can help medical device manufacturers comply with the good clinical practices (GCP), and secure an FDA investigational device exemption (IDE). Automated solutions for document control (or document management), training, CAPA and nonconformances in addition to analytics software for analyzing clinical data, are critical to the success of a medical device company.
For More Information on FDA IDE
For more information about solutions that can help medical device companies obtain FDA IDEs at a faster rate, please feel free to contact a MasterControl representative.