Innovative Health Sciences has successfully obtained the exclusive Medical Device Regulations Quality Management System (CE MDR QMS) certificate from BSI, a leading notified body, facilitating the introduction of Insignis™ Infusion System on the global market.
CHESTER, NY, January 15, 2025 /PRNewswire/ — Innovative Health Sciences (IHS) is proud to announce a remarkable milestone in its journey to introduce Insignis™ Infusion System on the global market. The company has successfully completed the difficult final stage of the two-stage European Medical Device Regulation (MDR) Quality Management System (QMS) audit conducted by BSI. THE Badge system addresses a critical unmet need in the infusion market for a portable and affordable mechanical syringe infusion device that accurately and safely administers medications intravenously and subcutaneously. With our FDA premarket clearance received on March 1, 2024our technologically disruptive and low-cost solution A remarkable perfusion system is now poised to become a new standard for routine infusions worldwide.
Achieving MDR compliance at such an early stage highlights the dedication and expertise of the IHS team. This rigorous process required meticulous adherence to MDR standards in all aspects of the device lifecycle, including design, manufacturing and post-market monitoring.
The importance of meeting MDR certification requirements for our business cannot be overstated. Existing marketing authorizations in the EU under the CE mark will expire soon and the difficult MDR certification is accepted not only in the EU, but in several countries around the world.
A collaborative team effort
The success of this audit is a testament to the extraordinary accomplishments of the IHS team. Leading the charge were the director of regulatory affairs, Sheppard bent and Senior Quality Engineer, Tejasree Yenigalla. Their work was supported by a senior mechanical engineer, Riad Ghaniknown for his multifaceted skills; Senior Quality Technician, Cristina Berkeley; Marketing Director, Tyler Kinner; and document control specialist, Tim Tate – all of whom contributed enormous additional effort to our smooth collaboration with the audit group.
“This achievement propels our company into global markets with a revolutionary and highly versatile system that will make life-saving medicines more accessible,” said Andy SealfonCEO of IHS. “Given the growing demand for reliable and affordable infusion systems – driven by natural disasters, military needs, an aging population and the increasing prevalence of chronic diseases – the Badge system is in a unique position to save and improve many lives. »
About the Insignis Infusion System
THE Insignia Syringe Infusion System is a robust, non-electrical device designed for routine subcutaneous and intravenous drug administration. Portable, lightweight, precise and easy to use, it is ideal for working with a wide range of medications and environments.
With 40 years of expertise in subcutaneous drug delivery, our design team has developed capabilities to infuse large volumes with shorter infusion times, reducing patient pain and discomfort . THE Badge system is particularly effective for patients requiring subcutaneous immunoglobulin (SCIg) for primary or secondary immunodeficiency and neuromodulation therapies. These additional subcutaneous therapies include deferoxamine, factor, anti-nausea medications, and monoclonal antibodies.
Looking ahead, IHS is exploring breakthrough applications for subcutaneous delivery of antibiotics (e.g., ceftriaxone, ampicillin, gentamicin), hydration, apomorphine, anti-infectives and drugs cardiac support. These innovations aim to expand patient access to simpler and more effective infusion solutions.
The future is bright for the A remarkable perfusion systemas it is poised to transform the infusion landscape, reach millions of underserved patients and improve outcomes worldwide.
SOURCE Innovative Health Sciences LLC
