The European Commission defined the following improvements of EU MDR over the previous MDD:
As with any regulatory change, the first step is to determine the gap between your current quality system and the new requirements. Our team of experts can support your organization by reviewing your quality management system documentation and historical product files to determine the most expeditious pathway to remaining in the European market. Whether additional testing is required to demonstrate state of the art compliance or rationale to bridge a perceived gap, we can review your files with the new requirements in mind and prepare and execute a clear strategy for MDR compliance.
SEE MORE SOLUTIONSOur team specializes in understanding and interpreting complex regulations. They stay abreast of updates, ensuring that your organization receives accurate and up-to-date information about EU MDR requirements.
We can assess your specific products, processes, and organizational structure to develop customized compliance strategies unique to your organization.
EU MDR places a strong emphasis on risk management. ECI can guide your organization in implementing effective risk management processes, helping to identify, assess, and mitigate risks associated with your medical devices.
Our regulatory experts can streamline the preparation and submission of documentation required for compliance.
ECI can help interpret the specific standards and requirements necessary to meet the criteria for safety and performance.
Our quality experts can assist in the remediation, development, and implementation of an effective and EU MDR compliant QMS.
ECI can provide training sessions for your internal teams, ensuring that employees are aware of the latest regulatory requirements and understand their roles in maintaining compliance.
Why not see for yourself the value ECI provides to clients through technology transfer? Find insight on how we support customers through case studies specific to technology transfer.
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Engaging ECI provides peace of mind, knowing that your organization is proactively addressing regulatory requirements. Contact ECI today to discuss your specific requirements and learn how our solutions can simplify the path to MDR compliance for your organization.
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