Innovative Health Sciences has successfully secured the exclusive Medical Device Regulations Quality Management System Certificate from BSI (CE MDR QMS), a leading notified body, thus facilitating the introduction of the Insignis™ Infusion System into the world market.
CHESTER, N.Y., Jan. 15, 2025 /PRNewswire/ — Innovative Health Sciences (IHS) proudly announces a remarkable milestone in its journey to introduce the Insignis™ Infusion System into the global market. The Company successfully passed the challenging final stage of the two-stage audit for the European Medical Device Regulation (MDR) Quality Management System (QMS) conducted by BSI. The Insignis System addresses a critical unmet need in the infusion market for an affordable, portable mechanical syringe infusion device that accurately and safely delivers medications both intravenously and subcutaneously. Together with our FDA premarket clearance received on March 1, 2024, our technologically disruptive and lower-cost Insignis Infusion 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 a meticulous adherence to MDR standards across all aspects of the device lifecycle, including conception, design, manufacturing, and post-market surveillance.
The importance of meeting the requirements for MDR certification for our Company cannot be overstated. Existing marketing clearances in the EU under CE Mark are expiring shortly and the arduous MDR certification is accepted not only in the EU, but in several countries throughout the world.
A Collaborative Team Effort
The success of this audit is a testament to the extraordinary achievements of the IHS team. Leading the charge were Regulatory Affairs Director, Sheppard Bently and Lead Quality Engineer, Tejasree Yenigalla. Their work was supported by Senior Mechanical Engineer, Riad Gani, known for his multifaceted skills; Senior Quality Technician, Cristina Berkeley; Marketing Director, Tyler Kinner; and Document Control Specialist, Tim Tate – all of whom contributed tremendous extra effort towards our seamless collaboration with the auditing group.
“This accomplishment propels our company into global markets with a groundbreaking and highly versatile system that will make life-saving medications more accessible,” said Andy Sealfon, CEO of IHS. “Given the increasing demand for reliable and affordable infusion systems– driven by natural disasters, military needs, aging populations, and the growing prevalence of chronic diseases—the Insignis System is uniquely positioned to save and improve many lives.”
About the Insignis Infusion System
The Insignis Syringe Infusion System is a robust, non-electric device designed for routine subcutaneous and intravenous medication delivery. Portable, lightweight, accurate, and easy to use, it is ideal to operate for a wide range of medications and environments.
With 40 years of expertise in subcutaneous medication delivery, our design team has developed capabilities for infusing large volumes with shorter infusion times, reducing pain and discomfort for patients. The Insignis System is particularly effective for patients requiring subcutaneous immunoglobulin (SCIg) for Primary or Secondary Immune Deficiency and neuromodulation therapies. These additional subcutaneous therapies include deferoxamine, factor, anti-nausea drugs, 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 cardiac support medications. These innovations aim to expand patient access to simpler and more effective infusion solutions.
The future is bright for the Insignis Infusion System, as it stands ready to transform the infusion landscape and reach millions of unserved patients and improve outcomes worldwide.
SOURCE Innovative Health Sciences LLC
