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Arkin Consulting Group LLC
1733 Canton Ln.
Marietta, GA 30062-2679
Tel: 770-565-6166
Fax: 770-565-9762
E-mail: info@arkinconsulting.com
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Description:
Provides strategic regulatory, consulting, submissions, QA, and compliance services, including QSR, GxP, ISO, QSIT, and design control audits, training, and consulting; 510(k) and IDE/PMA submissions; validations; process improvement; and response/resolutions for 483s, warning letters, MDR, and recall. Also offered is development of quality systems for FDA, ISO 9000:2000, ISO 13485, and CE mark requirements.
Categories this company is listed under in the Medical Electronics Suppliers Directory:
- Electronic Manufacturing Services: CE Marking Services (89 companies)
- Electronic Manufacturing Services: GMP Procedures (93 companies)
- Electronic Manufacturing Services: ISO 9000 Qualifications (253 companies)
