Medical Devices

Services Offered

MAVEN offers the following end-to-end Regulatory services for medical devices and In-vitro Diagnostics

Maven Expertise:

US Region	European Union	Canada
MAVEN guides you in registering the device based on the following compulsory approval procedures for the US FDA Region.	MAVEN aids in making the approval process easier in the European Union and is adept in tackling the multi lingual and complex regulations of different agencies.	MAVEN can accelerate the device approval by getting the licences to market in Canada.
Pre-market notification 510(k) Pre-market approval (PMA) 513(g) Applications Premarket Approval applications De Novo Petition Establishment Registration and Device Listing Medical Device Gap Analysis Local Agent Service	Technical File Preparation and Submission CE Marking and Approvals ISO QMS Certification EU MDR Support Appointing Authorised Representative	Medical Device Establishment License (MDEL) Medical Device License (MDL)