🎓 Our Educational Services

Practical Training on Medical Device Regulations and Quality Systems

For companies operating in the medical device sector, possessing regulatory knowledge is not only a legal requirement but also fundamental to quality, safety, and market access. At Era Management, we empower your teams by offering technical and practical training in MDR, IVDR, ISO standards, and clinical processes.

Our training programs are tailored specifically to technical experts, quality/regulation teams, and clinical or R&D departments. They can be offered on-site, online, or in a hybrid format upon request.

📘 Our Training Topics

Subject Heading Explanation
ISO 13485: Quality Management System Standard structure, application examples, audit preparation.
ISO 14971: Risk Management Risk analysis, FMEA applications, risk acceptance criteria.
2017/745 MDR Training Basic structure, classification, technical file, PMCF processes
2017/746 IVDR Training Risk classification and performance data for in-vitro diagnostic devices.
ISO 62366: Usability Engineering User interface, usability assessment, test plans
Preparing Technical Documentation Annex II & III requirements, file format and content control.
GSPR Training (Annex I) Interpretation of general safety and performance requirements.
Post-Sales Monitoring (PMS & PMCF) Data collection, analysis, and integration with CAPA.
Clinical Evaluation & Research CER preparation, ISO 14155, types of work, data sources.
Introduction to Biomechanical Testing Types of mechanical tests, planning, test environments, and evaluation.
Internal Audit Training (ISO 13485) Audit planning, checklists, reporting, and nonconformity management.

🎯 Training Format & Participants

Our Training Formats

  • 📍 In-person (In-house or at our headquarters)
  • 🌐 Online (via live or recorded platforms)
  • 🧪 Practical (case analysis, scenario solving, group work)

Who should attend?

  • • Quality and regulation teams, experts who prepare technical files.
  • • Clinical research and R&D teams, product managers and engineers
  • • Recent graduates and professionals transitioning to the field

✅ Why Era Management?

  • ✔ Training content is updated according to current industry trends.
  • ✔ ISO, MDR, FDA and IVDR certifications are provided by our experts.
  • ✔ An optional certificate is offered after the training.
  • ✔ Content tailored to your specific goals before each training session.
  • ✔ Makes learning easier with real-life case examples.

📥 Training Request Form

👉 Contact us to plan a training program tailored to you or your company.

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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