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.
| Service Type | Explanation |
|---|---|
| Full Internal Audit | Evaluation of all quality management system components. |
| Comprehensive MDR/IVDR Evaluation | Regulation-specific documentation and process control. |
| Pre-Audit | System testing before certification or NB audit. |
| Thematic Audits | Targeted audits focusing on specific modules/topics |
| Trained Supervision (Mentoring) | Implementation supported by internal team training during the audit. |
| MOC Audit | Verification of the planning, implementation, and documentation of change management processes. |
👉 Contact us to assess your company's internal audit needs.
We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.
Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.
The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.
Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.
We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.
For details about our management systems processes and corporate consulting services, please contact us.
