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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), IDE, PDP and PMA 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 and cosmetics industries.
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