Regulatory, Quality and Operations Management Consultants to the Medical Device Industry. Specialties: *Food and Drug Administration, CDRH; *510(k), IDE, PMA, PDP, 513(g), etc. submissions *Design Controlled Product Development Programs; *Medical Device Classification Determinations; *Customized QSR program installation, auditing and corrective action projects; *Interim RA/QA and Operational P/L Management; *Regulatory Due Diligence; *Clinical Management and Sponsor Oversight; *Recall Determinations, Strategy and Management; *Risk Assessments, Product and Business; *Complaint, MDR, CAPA, Design Control, Manufacturing Management *FDA 483 Inspections; Warning Letters, Consent Decree, Responses and Remediation Programs; *Our partnerships include leading Scientific, Research&Development;, Manufacturing,Testing and Legal Institutions. Specialties FDA Medical Device Management Consultancy
| Website | http://www.biodevicesolutions.com |
| Revenue | $982000 |
| Employees | View employees |
| Founded | 1999 |
| Address | 2607 Woodruff Rd, Simpsonville, South Carolina 29681, US |
| Phone | +1 760-574-9476 |
| Industry | Medical Devices & Equipment, Manufacturing |
| Competitors | Siemens, GE HealthCare, Johnson & Johnson, Roche, Medtronic, Thermo Fisher Scientific, Abbott, Stryker, BD, Boston Scientific +39 more (view full list) |
| SIC | SIC Code 737 Companies, SIC Code 73 Companies |
| NAICS | NAICS Code 54 Companies, NAICS Code 54151 Companies, NAICS Code 541 Companies, NAICS Code 541512 Companies, NAICS Code 5415 Companies |
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The BioDevice Solutions annual revenue was $982000 in 2026.
BioDevice Solutions is based in Simpsonville, South Carolina.
The NAICS codes for BioDevice Solutions are [54, 54151, 541, 541512, 5415].
The SIC codes for BioDevice Solutions are [737, 73].