Resources

Below is a list of useful links…

US Food and Drug Administration (FDA)

• Home Page
• Medical Devices
• MAUDE Database
• Medical Device Recalls
• Warning Letters
• Clinical Trials

California Food and Drug Branch (FDB)

• Home Page
• Certificates and Licenses

European commission

• Home Page
• Medical Devices
• MEDDEV Guidance

Authorized Representative(s)

• EMERGO Group (United States Website)

Notified Bodies (registrars)

• National Standards Authority of Ireland (NSAI)
• British Standards Institution (bsi America)
• SGS North America Inc.