{"id":4188,"date":"2026-05-22T11:00:48","date_gmt":"2026-05-22T08:00:48","guid":{"rendered":"https:\/\/demo.erayonetim.com\/?post_type=event&p=4188"},"modified":"2026-06-22T12:20:03","modified_gmt":"2026-06-22T09:20:03","slug":"internal-audit-service","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/ic-denetim-hizmeti\/","title":{"rendered":"Internal Audit Service"},"content":{"rendered":"

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\ud83d\udcdd Internal Audit Service<\/h4>\n

Independent Internal Audit Support Compliant with ISO 13485, MDR, FDA, and MOC Audit Standards.<\/h4>\n

For medical device manufacturers, internal auditing is a critical step in ensuring the sustainability of quality management systems, early detection of nonconformities, and preparedness for audits. At Era Management, we offer customized, impartial internal audit services under ISO 13485, MDR (2017\/745), IVDR (2017\/746), and FDA QMSR standards.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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\ud83e\udde9 Areas We Can Monitor<\/h3>\n
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  • \u2022 ISO 13485 quality management system<\/li>\n
  • \u2022 Risk management (ISO 14971)<\/li>\n
  • \u2022 Technical documentation and record control<\/li>\n
  • \u2022 Post-sales monitoring and PMCF processes<\/li>\n
  • \u2022 Product classification and MDR\/IVDR compliance<\/li>\n
  • \u2022 Supplier control and outsourcing management<\/li>\n
  • \u2022 Training, traceability, CAPA and non-conformity monitoring<\/li>\n
  • \u2022 FDA QMSR (21 CFR 820) basic compliance analysis<\/li>\n
  • \u2022 Change Management (MOC) audit<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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    \ud83d\udee0\ufe0f Our Working Method<\/h3>\n
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    • 1. The scope of the audit will be determined in consultation with the company.<\/li>\n
    • 2. A confidentiality agreement (NDA) will be made if necessary.<\/li>\n
    • 3. The audit plan and checklist are shared.<\/li>\n
    • 4. On-site or online monitoring is carried out.<\/li>\n
    • 5. The findings are reported with suggestions for improvement and evidence.<\/li>\n
    • 6. Follow-up actions are planned (optional).<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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      \ud83e\uddd1\u200d\u2696\ufe0f Our Service Types<\/h3>\n\n\n\n\n\n\n\n\n
      Service Type<\/th>\nExplanation<\/th>\n<\/tr>\n
      Full Internal Audit<\/td>\nEvaluation of all quality management system components.<\/td>\n<\/tr>\n
      Comprehensive MDR\/IVDR Evaluation<\/td>\nRegulation-specific documentation and process control.<\/td>\n<\/tr>\n
      Pre-Audit<\/td>\nSystem testing before certification or NB audit.<\/td>\n<\/tr>\n
      Thematic Audits<\/td>\nTargeted audits focusing on specific modules\/topics<\/td>\n<\/tr>\n
      Trained Supervision (Mentoring)<\/td>\nImplementation supported by internal team training during the audit.<\/td>\n<\/tr>\n
      MOC Audit<\/td>\nVerification of the planning, implementation, and documentation of change management processes.<\/td>\n<\/tr>\n<\/table>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n
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      \u2705 Your advantages<\/h3>\n
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      • \u2714 Unbiased and professional external review<\/li>\n
      • \u2714 Early detection of adjustment deficiencies<\/li>\n
      • \u2714 Preparation for NB or authority supervision<\/li>\n
      • \u2714 Reported, documented, and standard-based findings<\/li>\n
      • \u2714 Post-audit support (CAPA recommendation, re-audit)<\/li>\n
      • \u2714 Effective control of your change management (MOC) processes<\/li>\n<\/ul>\n
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        \ud83d\udce5 Request an Internal Audit!<\/h4>\n

        \ud83d\udc49 Contact us to assess your company's internal audit needs.<\/p>\n

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