Market Compliance Consulting

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 licenses 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)