Medical Device FDA Compliance Submission

COMPANY SERVICES

FDA Submissions

FDA Compliance

Audit Preparation

Inspection Preparation

Warning Letter Response

International Regulatory Affairs

Quality Systems Compliance

Training

Due Diligence

Contract Mfg & Distribution

Reimbursement

Design Development Project Mgmt

CORRECTIONS & REMOVALS

Could your field service event be in violation of FDA regulations?
Field service events must be considered for potential Corrections & Removals (recalls).

Do you know when a communication to the field qualifies as a Market Withdrawal or Corrections & Removals?

REU Associates can help you correctly assess recall classifications and avoid costly and public warning letters.

Labeling & Marketing Review

FDA and international regulatory authorities are now routinely monitoring company web sites. Competitors are scrutinizing promotional literature for opportunities to make trade complaints.

REU Associates will work with your Marketing & Engineering staff to develop promotional materials that are in compliance with your product claims, as well as US and international regulatory requirements