Lake Region Medical offers in-house clinical and regulatory services to submit and gain regulatory approvals in any geography. We can obtain approvals for customers or for Lake Region Medical as the legal manufacturer. We have extensive test methods that not only suit FDA profiling, ISO 11070 standards but also ensure product capability. In addition, we have standing advisory boards of interventional clinicians who can provide product feedback and clinical recommendations.
Key Capabilities Include:
Pre-clinical data and design history
510(k), CE Mark, SFDA (China), Shonin (Japan) and other
geographic submissions
Design history file compilation
Device master record management
Technical dossiers
PMA support
Clinical complaint management and failure analysis
