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Aniket Chaudhari's Blog (874)

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 August 19, 2024 at 1:36am — 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@…

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Added by Aniket Chaudhari on August 19, 2024 at 1:35am — 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 August 12, 2024 at 5:11am — 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@…

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Added by Aniket Chaudhari on August 12, 2024 at 5:10am — 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 August 12, 2024 at 5:09am — 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 August 12, 2024 at 5:07am — 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…

Continue

Added by Aniket Chaudhari on August 12, 2024 at 4:50am — 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 August 12, 2024 at 4:49am — 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 August 12, 2024 at 4:48am — 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 August 12, 2024 at 4:47am — 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.

Read more@…

Continue

Added by Aniket Chaudhari on August 5, 2024 at 2:50am — 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…

Continue

Added by Aniket Chaudhari on August 5, 2024 at 2:49am — 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 August 5, 2024 at 2:48am — 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 August 5, 2024 at 2:47am — 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…

Continue

Added by Aniket Chaudhari on July 29, 2024 at 3:11am — 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 July 29, 2024 at 3:10am — 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 July 29, 2024 at 3:10am — 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…

Continue

Added by Aniket Chaudhari on July 29, 2024 at 3:09am — No Comments

Customized machine design and manufacturer in Pune India

Pure Machine Design Pune is a precision-engineered heavy-duty drilling machine and custom drilling machine manufacturer in India. The unit is equipped with state-of-the-art best drilling machine tools facilities and is fully integrated to provide customers with one-stop resources to purchase sensitive drilling machines at leading prices online.

Read more@ https://www.puremachinedesign.com/

Added by Aniket Chaudhari on July 17, 2024 at 7:36am — No Comments

Jigs and fixture designer in Pune India

Locating and clamping are the critical functions of any work-holder. Fundamental principles of locating and clamping are applied while designing the Fixtures. Fixtures are custom work-holding devices used in many manufacturing operations to secure, support, and locate a work-piece. For more details you can write to [email protected] or call on +91 75880 70696 or visit here https://www.puremachinedesign.com/

Added by Aniket Chaudhari on July 17, 2024 at 7:35am — No Comments

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