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.
Frequently Asked Questions
How does the documentation and system setup process work?
What is the CE mark and why is it required for medical devices?
The CE mark is a legal mark indicating that a medical device complies with European Union regulations (MDR 2017/745/EU) and is safe to use. All medical device manufacturers are required to have the CE mark in order to participate in the European market.
What is a CRO (Contract Research Organization) and what does it do?
CRO (Course of Research Organization) is an organization that professionally handles processes such as planning clinical trials, ethics committee applications, project management, research center coordination, data management, monitoring, statistical analysis, and clinical reporting on behalf of the sponsor. In this way, it supports the completion of research in accordance with scientific, ethical, and regulatory standards.
Do you provide support after the consulting service?
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.
In which areas does Era Management offer consulting services?
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.
How does your privacy policy work?
We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.
How long does the ISO 13485 certification and consulting process take?
Depending on your company's existing infrastructure, product range, and organizational structure, the process is usually completed in 3 to 6 months using the simplest and most feasible systems.
Is it mandatory to prepare a Risk Management File in accordance with the ISO 14971 Standard?
Yes, implementing a risk management process in accordance with the ISO 14971 standard is mandatory for all medical devices. All risks that the product may pose, from design to the end of its life cycle, must be analyzed and documented.
Is it easy for companies with ISO 9001 certification to transition to ISO 13485?
Your ISO 9001 infrastructure will definitely simplify the process. By maintaining your existing system, we seamlessly integrate industry-specific requirements such as medical device-specific risk management and sterilization.
What data is collected during a clinical trial?
Depending on the purpose of the study, various data may be collected, including demographic information, clinical assessments, laboratory results, imaging findings, device performance data, adverse event records, and patient-reported outcomes. All data is processed in accordance with applicable data protection legislation.
What standards are used for conducting clinical trials?
Clinical trials are planned and conducted in accordance with applicable national legislation as well as relevant international standards and guidelines. In medical device research, ISO 14155, MDR (EU) 2017/745, the Helsinki Declaration, and relevant MDCG guidelines are particularly taken into account.
What is MDR (2017/745/EU)?
MDR (Medical Device Regulation) 2017/745 is the European Union's current legislation on medical devices. The MDR introduces more comprehensive requirements than previous directives regarding product safety, clinical evidence, traceability, and post-marketing surveillance.