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SII to acquire 20 pc stake in IntegriMedical

 SIIs expertise in vaccine manufacturing and global distribution will be invaluable as we work towards making our technology more widely accessible to patients worldwide, IntegriMedical Managing Director Sarvesh Mutha said. N-FIS will be available in the Indian private market, offering patients and healthcare providers an alternative to traditional needle-based injections, SII said. The technologys advantages include the elimination of needle-phobia, alleviation of pain during administration, convenience of use, and prevention of needle-stick injuries and cross-contamination, it added.   Vaccines manufacturer Serum Institute of India (SII) on Friday said it is acquiring 20 per cent stake in IntegriMedical, to advance needle-free injection system technology.   IntegriMedical has developed a US patented needle-free Injection System (N-FIS) that utilises high-velocity jet stream using mechanical power to effectively and consistently administer biologics and drugs, Serum Ins...
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USFDA Regulatory Consultants

 IZiel helps you to obtain US FDA and CE approvals for Class I, II & III Medical Devices. Our Regulatory Consultants in US, Europe and India have thorough knowledge of USFDA & MDR Requirements alongwith extensive experience in submissions and approvals. IZiel works with the company to develop comprehensive documents in compliance with the regulatory requirements.  Read more@ https://iziel.com/usfda-regulatory-consultants/   
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MDD to MDR

 IZiel along with 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/  
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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/   
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Regulatory Remediation Services

  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/usfda-consulting-firms/   
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FDA Remediation Consultants

 Remediation Consultants at IZiel implement best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries. IZiel provides expert solutions to remediate 483 observations and warning letters. IZiel teamworks with medical device companies across the globe to achieve regulatory andstandard compliance.  Read more@ https://iziel.com/usfda-consulting-firms/  
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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/   
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