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Favorable, timely reviews of medical device submissions by the FDA do not happen by chance. They depend on sound planning, management and expert knowledge in the preparation of your submission. The alternative is a costly and frustrating process that will delay or prevent your product from getting to market.

ECG offers cost effective, experienced consulting to medical device firms on FDA-related issues. Its services include:

  • Preparing 510(k) Submissions
  • Critique of Company-Devloped Draft Submissions
  • Response to FDA Deficiency Letters
  • Regulatory Strategy Development
  • Interpreting FDA Requirements
  • Preparing for and Participating in Meetings with the FDA
  • FDA Liaison
  • Regulatory Education and Training
  • Expert Witness Testimony

ECG is your submissions expert. ECG will ensure your technical information will fulfill FDA's latest requirements and facilitate its review. ECG's experience covers areas covered by the following Divisions of FDA's Center for Devices and Radiological Health (CDRH) including:

  • Clinical Laboratory Devices
  • Cardiovascular and Respiratory Devices
  • Dental, Infection Control, and General Hospital Devices
  • General, Restorative and Neurological Devices
  • Reproductive, Abdominal and Radiological Devices
  • Ophthalmic and ENT Devices

In addition, ECG offers services to the medical device industry through its referral network of consultants as well as services to the drug,cosmetics and dietary supplement industries.