LOGISTIC, MARKETING AND REGULATORY SERVICES

Consultants specialising in regulatory affairs

LOGITECH TRANSCONTINENTAL CORPORATION
WORLDWIDE CONSULTING 

 

 

Pre-IDE Consulting

 

The Pre-IDE meeting with the FDA is becoming an increasingly popular means to approach the FDA for assistance with various questions which a potential 510k, IDE or PMA submitter may have. In this more informal setting, the FDA has greater flexibility in answering your questions concerning Bench Test Protocols, mechanical studies, Biocompatibility, draft clinical or draft Human Factor studies, etc.

A definitive answer from the FDA can help you make an informed business decision concerning your route to approval and perhaps save investing capital in incorrect testing or clinical studies with less than beneficial outcomes, and more importantly time wasted in omission of crucial testing besides time wasted in useless testing.

This is a fixed fee service.