Medical Device Software Validation

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/  

 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/  

 IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.  Reaf more@ https://iziel.com/process-validation/  

 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 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-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/