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Aniket Chaudhari's Blog (785)

IQ OQ PQ Medical Devices

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/

Added by Aniket Chaudhari on April 19, 2024 at 7:40am — No Comments

Form 483 Remediation

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.

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Added by Aniket Chaudhari on April 19, 2024 at 7:38am — No Comments

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-approval/

Added by Aniket Chaudhari on April 19, 2024 at 7:38am — No Comments

MDD to MDR

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/

Added by Aniket Chaudhari on April 19, 2024 at 7:34am — No Comments

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-approval/

Added by Aniket Chaudhari on April 19, 2024 at 5:00am — No Comments

MDD to MDR

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/

Added by Aniket Chaudhari on April 19, 2024 at 4:59am — No Comments

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@…

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Added by Aniket Chaudhari on April 19, 2024 at 4:58am — No Comments

Form 483 Compliance

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/

Added by Aniket Chaudhari on April 19, 2024 at 4:57am — No Comments

MDD to MDR Consultant

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/

Added by Aniket Chaudhari on April 11, 2024 at 8:21am — No Comments

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…

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Added by Aniket Chaudhari on April 11, 2024 at 8:20am — No Comments

Remediation for Medical Devices

IZiel team in collaboration with the customer utilize an extensive & comprehensive methodology to complete the remediation project. Our Onshore-Offshore Model with strong project management ensure deliveries with faster timelines, flexible resources and in cost-effective manner.IZiel utilizes the best practices in design and development while ensuring compliance with regulation to ensure a speedy and compliant design and development process.

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Added by Aniket Chaudhari on April 11, 2024 at 8:19am — No Comments

USFDA Consulting Firms

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…

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Added by Aniket Chaudhari on April 11, 2024 at 8:19am — No Comments

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/

Added by Aniket Chaudhari on April 3, 2024 at 7:09am — No Comments

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@…

Continue

Added by Aniket Chaudhari on April 3, 2024 at 7:08am — No Comments

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/remediation/

Added by Aniket Chaudhari on April 3, 2024 at 7:08am — No Comments

MDD to MDR Consultant

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/

Added by Aniket Chaudhari on April 3, 2024 at 7:07am — No Comments

Form 483 Compliance

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/

Added by Aniket Chaudhari on April 3, 2024 at 5:13am — No Comments

USFDA Consultants Medical Device

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…

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Added by Aniket Chaudhari on April 3, 2024 at 5:12am — No Comments

IQ OQ PQ Medical Devices

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/

Added by Aniket Chaudhari on April 3, 2024 at 5:11am — No Comments

Form 483 Remediation

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@…

Continue

Added by Aniket Chaudhari on April 3, 2024 at 5:11am — No Comments

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