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In Vitro Diagnostics Suppliers Directory Index
Medical Device Auditing & Consulting Inc. (MDACI)
15210 Arminio Ct.
Darnestown, MD 20874-3633
Tel: 301/947-9165
Fax: 301/947-9208
E-mail: frank.twardochleb@mdaci.com
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Description:
Provides auditing and submission services to the in vitro diagnostics industry, including quality system compliance audits, certification, and corrective action plans; on-site employee training in FDA requirements; simulated FDA inspections; clinical studies; regulatory due diligence; and 510(k) and PMA submissions.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Process Development and Validation (62 companies)
- Consulting Services: Product R&D, Design (74 companies)
- Consulting Services: Product Testing (68 companies)
- Consulting Services: Quality Systems Certification (53 companies)
- Consulting Services: Regulatory Affairs (73 companies)
- Consulting Services: Site Selection, Facility Design (10 companies)
- Consulting Services: Software Design, Programming (32 companies)
