International Regulatory Submissions and Exports
Paladin Medical will help you think globally. If your company intends to market internationally, you need to know how your product will be regulated in major medical device markets. Compliance with FDA export and import regulations ensures smoother international access.
Companies based outside the USA will find Paladin Medical to be a productive and helpful service provider for FDA submissions. We serve as the US Agent for clients and help with compliance with regulations such as MDR reporting, recalls, and quality systems (CFR 820). Paladin Medical can also troubleshoot if your import is held in Customs.
Global Regulatory Strategy and Planning
Paladin Medical assists in strategic regulatory planning and quality development planning. Knowing the global regulatory requirements and applicable conformance standards is the starting point for medical device input requirements. We can help with:
- Global product requirements
- Exporting to regulated nations
- Import requirements for devices made outside the USA
- Serve as a US Agent to Paladin Medical clients
- Applications to Competent Authority for Class I products
- Technical Construction Files and Design Dossiers
- European product requirements for foreign compliance
- Canadian, European, Australian, Latin American, and Japanese submissions
Technical Construction Files and Essential Requirements Checklist
The rules can be confusing for a US-based company preparing their first Technical Construction File in anticipation of a European market introduction. Paladin Medical help you integrate your Design History File with the Design Dossier and your product DMR with the Technical Construction File contents.