Era Management has been providing consultancy services to medical device and IVD manufacturers on regulatory compliance and market entry since 2017. Our services primarily include technical documentation under ISO 2017/745 and ISO 13485, quality management system implementation and integration, testing and validation planning and execution, EUDAMED registration, infrastructure suitability, and preparation of technical documentation for local product registrations in various countries, including Turkey, China, Switzerland, Saudi Arabia, Hungary, France, and Greece. We are pleased to serve medical device manufacturers and stakeholders in these countries.
Frequently Asked Questions
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.
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For details about our management systems processes and corporate consulting services, please contact us.