iMDsoft raises the bar with the early attainment of EU Medical Device Regulation (MDR) Compliance for its MetaVision Clinical Information System

Tel Aviv, February 5, 2024 — iMDsoft , a global leader in healthcare technology solutions, is proud to announce the successful early attainment of CE certification for MetaVision, its Clinical Information System (CIS), meeting the stringent requirements of the European Union Medical Device Regulation (MDR). This critical milestone demonstrates iMDsoft's unwavering commitment to safety, backed up by clinical data and post-market monitoring (‘vigilance’ and ‘post-market surveillance’), product performance and regulatory compliance.

MDR Compliance: Raising the Bar for Patient Safety and product performance.

The MDR represents a pivotal shift in medical device regulation placing a significant emphasis on heightened patient safety measures, and enhanced traceability throughout the healthcare data lifecycle.

Compared to the previous Medical Device Directive (MDD), the MDR establishes a higher standard for Software Medical Devices, including clinical information systems. Manufacturers are now required to make a more significant commitment to ensuring the safety and performance of medical devices, focusing on clinical data, post-market surveillance, product’s usability, cybersecurity aspects and compliance with existing and state-of-the-art common criteria.

MetaVision Reclassification Demonstrates Commitment to Safety

Aligned with the more stringent MDR criteria, MetaVision's classification has been elevated from IIa to IIb, categorizing it among medium-to-high risk medical devices. This reclassification reflects the critical role that Clinical Information Systems play in managing patient data and underscores the trust clinicians place in this data to make informed decisions.

"We are thrilled to achieve EU MDR compliance for MetaVision, affirming iMDsoft's unwavering commitment to meeting industry standards for safety and performance," said Shahar Sery, EVP of iMDsoft. "This milestone reinforces our dedication to providing healthcare organizations with a robust and compliant CIS solution, ensuring uninterrupted market access and sustained service excellence across Europe and beyond."

Healthcare organizations seeking a reliable and compliant Clinical Information System are invited to explore how iMDsoft's commitment to EU MDR compliance can empower their operations. For more information, please visit www.imd-soft.com

About iMDsoft:

iMDsoft is a global leader in clinical information systems, delivering innovative solutions to enhance patient safety, streamline workflows, and improve clinical decision-making across critical care, acute care and anaesthesia environments. With a focus on compliance, iMDsoft continues to push the boundaries of excellence in healthcare technology.?? Hundreds of hospitals and health networks across 27 countries trust and use MetaVision, the company's flagship product, to improve patient care quality and enhance financial results. Our global channel partner program offers an end-to-end approach for distribution partners to deliver iMDsoft's best in class software. iMDsoft is a wholly owned subsidiary of N. Harris Computer Corporation.

For more information, please contact Nicole Levitt | [email protected]