Experienced in: - Regulatory Strategy and Regulatory Plan development for in vitro diagnostics and medical devices. - Experienced in submitting pre-market submissions and marketing authorization applications to FDA (510k, de novo, and PMA). - Experienced in drafting clinical and analytical validation protocols and summary reports. - Experienced in reviewing and providing feedback for IDEs and IRB documents. - Developing and auditing FDA and ISO 13485 compliant Quality Systems. - Experienced in reviewing and assisting in developing SBIR/STTR funding.
View Top Employees from BDRA Consulting, LLC| Website | http://www.bdraconsulting.com |
| Revenue | $6 million |
| Employees | 2 (1 on RocketReach) |
| Founded | 2012 |
| Address | 1 Clearwater Ct, Damascus, Maryland 20872, US |
| Phone | (301) 922-7231 |
| Technologies | |
| Industry | Retail, Medical and Diagnostic Laboratories |
| Competitors | Matrix Medical Devices, Paladin Medical®, Inc. |
| SIC | SIC Code 384 Companies, SIC Code 38 Companies, SIC Code 87 Companies, SIC Code 874 Companies |
| NAICS | NAICS Code 541 Companies, NAICS Code 54 Companies |
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BDRA Consulting, LLC Questions
The BDRA Consulting, LLC annual revenue was $6 million in 2024.
1 people are employed at BDRA Consulting, LLC.
BDRA Consulting, LLC is based in Damascus, Maryland.
The NAICS codes for BDRA Consulting, LLC are [541, 54].
The SIC codes for BDRA Consulting, LLC are [384, 38, 87, 874].
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