Medical Device Software Validation

  Needleless Systems : Beneficial for Patients and Healthcare Workers The Needle-Free Injection System is a needleless system that benefits both patients and healthcare workers. As there is relatively less pain, the needle-free injector eliminates patient anxietyand enhances patient compliance during the vaccination procedure. Also, healthcare professionals can completely prevent needle stick injuries and cross-contamination with needless injections.  Read more@ https://integrimedical.com/  

 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/  

 IZiel provides expert solutions to remediate FDA 483 observations and warning letters. IZiel team works with medical device companies across the globe to achieve regulatory and standard compliances. We take great pride in implementing best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries.  Read more@ https://iziel.com/remediation/