Posts

Needleless Systems

  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/  

MDD to MDR

 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/  

Configuration Management for Medical Device

 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/   

Needle Free Drug Delivery System

 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/  

Form 483 Compliance

 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/  

MDR Consultants

 IZiel Healthcare are leading providers of engineering and regulatory services for MDD to MDR projects for medical device companies.IZiel helps you to obtain CE approvals for Class I, II & III Medical Devices, along with MDD to MDR transitions.   Read more@ https://iziel.com/ce-approval-mdr/  

Remediation for Medical Devices

 IZiel team in collaboration with the customer utilize an extensive & comprehensive methodology to complete the remediation project. Our Onshore-Offshore Model with strong project management ensure deliveries with faster timelines, flexible resources and in cost-effective manner.IZiel utilizes the best practices in design and development while ensuring compliance with regulation to ensure a speedy and compliant design and development process.  Read more@ https://iziel.com/remediation/