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
  • 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 MEDDEV 2.12/2
  • Clinical Evaluation Reports (CERs) in accordance with MEDDEV 2.7.1
  • 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)

Devine Guidance International