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/

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.

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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/

Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA…

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/

Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA…

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.

Read 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.

Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA…

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.

Read 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@…

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/

Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA…

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.

Read more@ https://iziel.com/process-validation/

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/

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@…