Services Offered:

 

• FDA Submissions: 510(K), IDE, DMF, PMA, Product Reports. (Over 100 successful 510(k) clearances)

• FDA 483 and WARNING LETTER: Strategies and Responses

• cGMP Compliance Programs: AUDITING - CONSULTING

• FDA Registration and Listings: FDA now charges an annual fee for Establishment Registration. The fee changes each year.

• Official FDA Correspondent and/or Agent for Non-USA firms More information on US Agents

• Validations: Software, Process and Product.

• Risk and Hazard Analysis.

• GUDID Submissions. Barcodes now required on most medical devices. Unique Device Identification