7505 Fannin St. Ste 610
Houston, TX 77054
ph: 713-467-2607
fda510k
Services
- Traditional 510K Submission:
- Special 510K Submission:
- Abbreviated 510K Submission:
- Assist FDA / HC in communications with our clients.
- Respond to questions concerning our clients’ devices that are imported or offered for import into the United States and Canada.
- Audit quality management procedures and production process control for medical device manufacturers
- Assist FDA/HC in scheduling inspections of our clients’ manufacturing facilities.
- Notify FDA/HC Registration and renewal date for our clients.
- Maintain the establishment registration and device listing on behalf of our clients through FURLS site.
- Other US Radiology Regulatory related discussions (Additional fee may apply such as a written report and other market research)
- Human Factor Usability Engineering Test
- Clinical Trials
7505 Fannin St. Ste 610
Houston, TX 77054
ph: 713-467-2607
fda510k