Research, writing, monitoring tests, submitting, follow-through and/or review of FDA [510(k)], IDE and PMA applications
Manufacturing quality system evaluation, employee & cGMP training
MDR Complaint Handling Management
Technical assistance and reporting in the case of incidents reported by users, distributors, FDA. Organizes and conducts with the Manufacturer the Incident Reporting; and conducts assessment and determines the severity of incidents
Prepare a customized Quality System Manual for FDA GMP compliance (ISO compliance in the same manual is optional). Conducting client facility training concerning GMP regulations, design controls, process validations and other aspects of the GMP and worldwide medical device regulations.
Replies to FDA Form 483 and Warning Letters
How a company responds to an FDA 483 and/or Warning Letter could be the difference between not having further regulatory follow up to facing an injunction with regulatory penalties. USDeviceAgent.com has extensive experience in reviewing FDA documents, preparing a strategy for reply and follow up actions.
How to implement a Design Control System. What the Design Control System should be comprise of; input, output, FMEA, verification, validation, change control and design transfer are some of the areas that are addressed.
Research and prepare medical device manuals that meet FDA guidelines.
Representation before the FDA and
other authorities in case of recall or risk for product withdrawal from
the market.
Labeling data review (verification of compliance to FDA requirements)