Navigating the complexities of In Vitro Diagnostic Regulation (IVDR) is crucial for companies operating in the diagnostics industry. Our comprehensive solutions are designed to assist you in achieving and maintaining compliance with the latest IVDR requirements. ECI's experts can support your organization by reviewing your quality management system documentation and historical product files with the new requirements in mind to determine the most expeditious pathway to remaining in or entering the European market.
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Regulatory Consultation
Our team of experts provides personalized regulatory consultation services tailored to your specific needs. We help you understand the implications of IVDR on your products and guide you through the regulatory landscape.
Product Assessment & Classification
Ensure accurate product classification under IVDR guidelines. We conduct thorough assessments of your in vitro diagnostic products, aiding in their proper classification and determining the necessary conformity assessment procedures.
Technical Documentation Review & Enhancement
Prepare and review technical documentation to meet IVDR standards. We assist in compiling, reviewing, and enhancing technical files, ensuring they align with the regulatory requirements for successful conformity assessment.
Quality Management System (QMS) Implementation
Implement a robust Quality Management System aligned with IVDR standards. Our consultants work with you to establish and enhance your QMS, ensuring it meets the stringent requirements outlined in the regulation.
Post-Market Surveillance Support
Stay vigilant with our post-market surveillance support. We help you establish and maintain effective processes for monitoring and reporting the performance of your in vitro diagnostic devices in the market.
Regulatory Consultation
Our team of experts provides personalized regulatory consultation services tailored to your specific needs. We help you understand the implications of IVDR on your products and guide you through the regulatory landscape.
Product Assessment & Classification
Ensure accurate product classification under IVDR guidelines. We conduct thorough assessments of your in vitro diagnostic products, aiding in their proper classification and determining the necessary conformity assessment procedures.
Technical Documentation Review & Enhancement
Prepare and review technical documentation to meet IVDR standards. We assist in compiling, reviewing, and enhancing technical files, ensuring they align with the regulatory requirements for successful conformity assessment.
Quality Management System (QMS) Implementation
Implement a robust Quality Management System aligned with IVDR standards. Our consultants work with you to establish and enhance your QMS, ensuring it meets the stringent requirements outlined in the regulation.
Post-Market Surveillance Support
Stay vigilant with our post-market surveillance support. We help you establish and maintain effective processes for monitoring and reporting the performance of your in vitro diagnostic devices in the market.
Benefit from the knowledge and experience of our regulatory experts who are well-versed in IVDR requirements.
Our services are tailored to your unique business needs, ensuring a personalized approach to compliance.
Streamline the compliance process with our efficient and effective solutions, allowing you to focus on your core business activities.
Stay up-to-date with regulatory changes and receive ongoing support to adapt to evolving IVDR requirements.
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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Contact ECI today to discuss your specific requirements and learn how our solutions can simplify the path to IVDR compliance for your organization. Together, let's ensure the success and sustainability of your in vitro diagnostic products in the EU market.
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