Devine Guidance International, INC.
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Our Services Include
Quality Management System Assessments
Quality Management System Design & Implementation
Quality Manual Compliance Reviews
Quality Manual Generation
Installation of Effective Supplier Management Systems (21 CFR, Part 820; MDSAP; (EU) 2017/745; ISO 9001:2015; & ISO 13485:2016)
Supplier Audits
Internal Audits
Technical File Review (EU - Class IIa & IIb) & Technical File Generation
Essential Requirements Checklist Generation & Review
510(k) Review (US FDA - Class II) & 510(k) Generation
PMCF's in accordance with (EU) 2017/745 (MDR)
Clinical Evaluation Reports (CERs) in accordance with (EU) 2017/745 (MDR)
Corrective Action & Preventive Action (CAPA)
Complaint Remediation Activities
Response & Remediation of FDA Form 483 Observations
Response & Remediation Support for FDA Warning Letters
Review of Validations (IQ, OQ, PQ, & PPQ)
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