🧪 Clinical Data Collection and Clinical Research Services

Product-Specific Clinical Strategy Design in Accordance with MDR, IVDR, FDA, and ISO 14155.

Clinical data are indispensable for proving the safety and performance of medical devices, in accordance with MDR (2017/745), IVDR (2017/746), ISO 14155, and FDA regulations. At Era Management, we operate with a versatile CRO approach experienced in clinical data management specific to medical devices; we plan your clinical research, PMCF, and data collection strategies end-to-end as needed.

🔍 Product-Specific Clinical Approach

Criterion Its effect
Product Class Clinical data determines the need for and depth of the study.
Legacy Product Status Is bridging possible based on the existing data?
Proof of Similarity (Equivalence) Is it possible to use literature/equivalent products?
Market Time and Usage History The use of retrospective data and the necessity of PMCF.
Intended Use / Risk Profile Is a clinical trial sufficient, or is a literature review adequate?

📘 Our Services

📑 Clinical Assessment (MDR/IVDR)

  • • Clinical evaluation plan (CEP) & report (CER)
  • • Evaluation of existing data, literature, and equivalence.
  • • Expert opinion and methodological validity analysis

🔬 Clinical Research (ISO 14155)

  • • Prospective/Retrospective study, PMCF studies
  • • eCRF, consent forms, ethics committee support
  • • File structure suitable for reporting and NB/FDA submissions.
  • • Development of a clinical research strategy
  • • Preparation of Clinical Research Protocol
  • • Establishing evaluation criteria and conducting literature reviews.
  • • Preparation of the Informed Consent Form (ICF)
  • • ORF (Case Report Form) design
  • • Sampling calculation
  • • Statistical analysis plan
  • • Randomization
  • • Ethics committee applications
  • • TİTCK applications
  • • Job commencement Visits
  • • Monitoring
  • • Results reports

🤝 Collaborative Model

🔄 Flexible Team Structure:

  • • Team-based companies: We manage the processes (control/cost).
  • • Team requirements: We plan the site with our CRO partner.
  • • Physician/Center recommendation: We share clinical leadership.

📁 Deliveries

Protocol, ethics committee files, data collection tools, clinical trial contracts, and final outcome reports (CER/PMCF integration).

✅ Why Era Management?

  • ✔ Clinical consulting focused solely on medical devices.
  • ✔ Fully compliant process management with ISO 14155
  • ✔ Smart data strategies for “legacy” products
  • ✔ Integrated working model with the pharmaceutical CRO partner network.
  • ✔ Flexible structure that supports collaboration between physicians and the field.

📞 Contact Us!

👉 Contact us to develop a clinical data strategy or study plan for your product.

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.

Get More Information

For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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