Medical Device Software Validation

 IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for medical device manufacturers.  Read more@ https://iziel.com/software-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/form-483-compliance/  

 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-consulting-firms/  

 IntegriMedical has launched India's first Needle-Free Injection System to ease the pain of injections for children and adults, enhancing healthcare experiences.   Check into any pediatrician’s clinic and chances are you will hear little kids bawling. They’d be fine even during the doctor’s examination but the moment the injection is in the doctor’s hand the crying begins. And while this tears a young mother’s heart to see her baby cry, she understands that this is one ‘pain’ her child must endure and learn to accept. And if truth be told there are many adults too who fear the needle. So, what could be done?   Says Sarvesh Mutha, co-founder and managing director of IntegriMedical, “We looked at the problem deep and hard and felt that things should change. Injections should not be painful, not even for a nanosecond. That is when IntegriMedical developed the Needle Free Injection System (NFIS) in April 2024.”   Read more@ https://www.hindustantimes.com/cities/pune-new...

 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 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-consulting-firms/