Devine Guidance International, INC.

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)