📂 MDR (2017/745) Adaptation Counseling

Your Guarantee of Compliance with European Union Legislation for Medical Devices

The European Union's new regulation for medical devices, MDR (EU) 2017/745, aims to maximize patient safety by introducing much more comprehensive and stringent requirements than the previous MDD directive. Full compliance with this regulation is mandatory for all medical device manufacturers in order to participate in the European market.

At Era Management, we understand your obligations under the MDR and help you comply in a strategic and sustainable way.

Services

  • ›MDR Compliance Assessment (Gap Analysis): We analyze your current system's compliance with MDR and identify areas for improvement.
  • ›Technical File Preparation: Preparation of technical files and clinical evaluation documents in accordance with Annex II and Annex III of the MDR.
  • ›Product Classification: The MDR (2017/745) classifies medical devices according to their risk levels and sets different certification, clinical data, and traceability requirements for each class. Correctly classifying your product ensures that the entire compliance process is based on sound principles. We help you determine the correct classification by considering your product's purpose, mode of use, duration of use, and invasiveness (Annex VIII).
  • ›Improving Risk Management Processes: Establishing a risk management structure integrated with ISO 14971.
  • ›Clinical Assessment and Follow-up: Establishing a clinical data strategy in accordance with MEDDEV and MDCG guidelines.
  • ›Consultancy on the Person in Charge (PRRC) Process: Meeting personnel requirements under Article 15 of the MDR.
  • ›Labeling and UDI Consulting: MDR-compliant product labeling, symbols, and EUDAMED registration processes.
  • ›Audit Preparation: System preparation and internal audits prior to Notified Body audits.
  • ›Product Classification and Borderline Consulting: Accurate product classification and development of regulatory strategies.

Benefits of MDR Adaptation

  • ✓Protecting access to the European market.
  • ✓Increased patient and user safety.
  • ✓Full compliance with regulator and accredited body expectations.
  • ✓Strengthening brand reputation and reducing risks.

✅ Why Era Management?

●Industry experience in MDR and ISO 13485.
●National and international experience
●A holistic approach to clinical, technical, and regulatory issues.
●A solution-oriented consulting model tailored to your company.
●End-to-end support in certification processes.

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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