Medical Device Software Validation

  Injection without Needle : A Revolutionary Technology The idea of injections can give sleepless nights to kids and even some adults. But not anymore! Introducing IntegriMedical’s Needle-Free Injection System, which gives an injection without a needle. Safe, painless, and effective, the needleless injection is set to transform the vaccination process.  Read more@ https://integrimedical.com/   

 The Serum Institute of India (SII), has announced a strategic investment in IntegriMedical, acquiring a 20% stake in the company. This collaboration aims to advance the development and deployment of Needle-Free Injection System (N-FIS) technology.   This partnership aligns with SII’s vision of ‘Health for All’ and IntegriMedical’s mission to ‘Transform Healthcare Globally.’ Together, they aim to provide patient comfort, increase compliance, reduce needle-stick injuries, and enhance the efficacy of liquid medications via needle-free dispersion.   IntegriMedical has developed a US-patented Needle-Free Injection System that uses a high-velocity jet stream powered mechanically to administer biologics and drugs effectively. This innovative drug delivery solution aims to alleviate pain during administration, providing needle-phobic patients with a stress-free experience.   Read more@ https://themachinemaker.com/news/serum-institute-of-india-makes-strategic-investment-in-...

  The device administers medication through the skin using a high-pressure, hair-fine jet, eliminating the need for traditional needles. Pune-based medtech startup IntegriMedical has unveiled a needle-free, spring-powered injection device aimed at making drug delivery safer and virtually painless. The device administers medication through the skin using a high-pressure, hair-fine jet, eliminating the need for traditional needles. Founded in 2020 by Sarvesh Mutha, Ankur Naik, Scott McFarland, and Mark Timm, the company seeks to address both patient needle phobia and healthcare worker safety risks. “Needle phobia is more than just fear—it can cause patients to skip life-saving treatments,” said Sarvesh Mutha, Managing Director, IntegriMedical. He added that the device also reduces the risk of needle-stick injuries and cross-contamination for healthcare professionals. The Needle-Free Injection System (N-FIS) uses a stainless-steel piston and a disposable cartridge to delive...

 IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.  Read more@ https://iziel.com/ce-approval-mdr/  

 IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) and resolve queries, if any, from USFDA. Read more@ https://iziel.com/configuration-management/   

 Multi-Fold Benefits of Needle-Free Drug Delivery System IntegriMedical’s needle-free drug delivery system is beneficial for patients as it offers a nearly painless injection process. Moreover, it is beneficial for healthcare professionals, as it eliminates needle-stick injuries and chances of cross-contamination. As there are no needles, there is no need for a special disposal system, making it eco-friendly as well.  Read more@ https://integrimedical.com/