Aniket Chaudhari's Blog – March 2021 Archive (10)

The biological evaluation of medical devices takes a new direction.

Biological evaluation is an essential part of medical device right from the beginning and there are lot of advancement happening as the progress in technology happens and the experience that gained over a period in this field.

It goes without saying that people got to be shielded from the potential biological risks that would arise from the utilization of medical devices, yet the range of biological hazards is wide and sophisticated.…

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Added by Aniket Chaudhari on March 24, 2021 at 1:00am — 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.

https://iziel.com/fda-remediation-consultants/

Added by Aniket Chaudhari on March 23, 2021 at 7:51am — 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 March 23, 2021 at 7:50am — 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.

https://iziel.com/form-483-compliance/

Added by Aniket Chaudhari on March 18, 2021 at 1:40am — 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.

https://iziel.com/regulatory-remediation/

Added by Aniket Chaudhari on March 18, 2021 at 1:38am — 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.…

Continue

Added by Aniket Chaudhari on March 11, 2021 at 4:46am — 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.

https://iziel.com/form-483-compliance/

Added by Aniket Chaudhari on March 11, 2021 at 4:23am — 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.

https://iziel.com/regulatory-remediation/

Added by Aniket Chaudhari on March 11, 2021 at 4:22am — 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.

https://iziel.com/fda-remediation-consultants/

Added by Aniket Chaudhari on March 3, 2021 at 1:29am — 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.

https://iziel.com/regulatory-remediation/

Added by Aniket Chaudhari on March 3, 2021 at 1:28am — No Comments

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