MAVEN guides you in registering the device based on the following compulsory approval procedures for the US FDA Region.
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
European Union
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.
Technical File Preparation and Submission
CE Marking and Approvals
ISO QMS Certification
EU MDR Support
Appointing Authorised Representative
Canada
MAVEN can accelerate the device approval by getting the licences to market in Canada.
Medical Device Establishment License (MDEL)
Medical Device License (MDL)
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.