FDA

Our services include developing the clinical protocol, setting up and interacting with the IRB (Institutional Review Board), submitting the IDE (Investigational Device Exception), recruiting and working with the investigator, monitoring the trials, data gathering and analysis, project management, and statistical analysis.

Medra+ will assist our clients from scratch to end.   by supporting them to register their facility by the creation of user account, DUNS number, PIN / PCN number, and finally results in getting the device listed.

• A 510(k) is a required method that must be approved by the FDA to market the client’s product in the US. A 510(k) must be submitted for certain Class I devices, Class II, and certain Class III devices where similar products are already in the market.
• A PMA (Premarket Approval) is a required application that must be sent to the FDA in order to market a product in the U.S. A PMA is required for certain Class II and Class III devices where no predicate device exists in the market
• A DMF (Device master file) is one that is submitted to the FDA which includes technical, clinical, and safety information about a medical device component or material.
• A De Novo is a required application that must be sent to the FDA in order to market a product in the U.S. This includes devices that do not fall within any existing classification regulation, where the De Novo requester either determines that there is no predicate device or has received an NSE (Non- substantially Equivalent) determination on a 510(k) submission.

• Preparing Cover letters that are very clear and self explainatory, , technical documents, and/or include predicative device comparison.
• Classification of a device
• Select correct predicate devices for 510(k) submission
• Our team has in-depth knowledge on how to submit these applications and will have co-operation with our clients to get relevant information of the products to develop quality documents.
• Supports right from the Design and development phase tothe post-marketing design changes.

A local U.S. Agent is mandatory to designate FDA US Agent by establishments located outside USA for better communication with the FDA Authorities.

Medra Plus LLC is a local agent for foreign medical device manufacturers in accordance with the US FDA regulations. Medra Plus LLC will assist with FDA registration and reporting, provide guidance with FDA requirements for the iclients, assist with FDA guidelinesand monitor client’s facility to comply with the FDA Rules. xFDA compliance.