Medical Device Software Validation

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.   Read more@ https://www.devdiscourse.com/article/health/2941569-sii-to-acquire-20-pc-stake-in-integrimedical

Medical device manufacturers receive observations ( Form 483 ) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy.  Read more@ https://iziel.com/remediation/  

 IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. 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) for USFDA Approvals.  Read more@ https://iziel.com/usfda-approval/  

  Painless Injection: Introducing the New-Age Technology Injections have always been associated with pain and fear. But not anymore, thanks to IntegriMedical’s Needle-Free Injection System. It is a relatively painless injection and can be used for intramuscular and subcutaneous injections and ensures broad dispersion and effective absorption of the drug or biologics. Read more@ https://integrimedical.com/   

 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/  

  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/remediation/