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The CRO Group Inc.
P.O. Box 1098
Melrose, MA 02176
Tel: 888/881-5637
Fax: 781/665-5547
E-mail: info@crogroup.com
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Description:
Offers contract quality and regulatory services for IVD product developers and manufacturers. Services include IVDD and MDD CE marking; FDA QSR 21 CFR 820, ISO 13485:2003, and CMDCAS (Canada) consulting, training, and auditing; design documentation; clinical studies; product and manufacturing/QC software testing and documentation; software-related 510(k)s; and electronic signature/record 21 CFR 11 audits and remediation.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- 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 (74 companies)
- Consulting Services: Software Design, Programming (33 companies)
