Clinical Trials

T.A.B.S. provides a full range of Clinical Investigation/Study Services for the Medical Device Industry. With T.A.B.S. expertise, we can assist in the design of your clinical study from Protocol Development, selection of Clinical Investigators, Training, Monitoring and Total Management of the study with Database Design, Implementation and On-Going Progress and Final Review and Reporting to ensure Regulatory Compliance with GCP and GLP.

Regulatory Strategies

Strategic Planning is paramount for any company in the development of New Technologies and Medical Devices.  T.A.B.S. provides a full range of Regulatory Expertise to assist and support Medical Device Companies to ensure Regulatory Compliance for each stage of Product Development through Market Release and beyond.

· Preparation of FDA Registration and Device Listing

· Preparation of Premarket Notification Submissions

               Product Development Protocol (PDP)

               Investigational Device Exemption (IDE)

               Premarket Approval Application (PMAA)

               510(k) Notification

·    Liaison with FDA for Regulatory Actions, Warning Letters, Recall Response and MDR Reports

               Warning Letters

               QSR Inspection Deficiency Notices (FDA Form FD-483) Response

               Assessment of Recall Strategy

               Assessment of Medical Device Reporting Strategy   and Report

Authorized U.S. Agent

Registered with the FDA as an Authorized US Agent and for medical device establishments located outside of the United States. The FDA issued a regulation that became effective February 2002 requiring non-U.S. medical device establishments that market their products in the United States to register their companies and identify a US Agent as their official correspondent

     Copyright 2006 Texas Applied Biomedical Services Inc. All rights reserved