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Best practices for implementing design controls for the medical device industry

Lot of guidelines and regulatory requirements are available for this topic and general steps in chronological orders are defined. However how to make them effective is question. It is a requirement that all manufacturers must follow those requirements through establishing proper system within organization so that all devices produced are safe to use. Just to give you an example. To ensure the standard of medical devices, the…See More
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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.https://iziel.com/mdr-consultants/See More
Jan 18
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3 ways to change your mind regarding risk management

I hate Risk Management. There, I said it. And I am not the only one actually. Many of us are thinking that the Risk management is terrible! Please note that Risk Management is integral part of medical device and nobody can do away with this, so it needs t be embraced. With feeling of hate it will be difficult to implement this process with true potential. This system, no doubt is slightly complex and requires some training and in-depth knowledge for its application. Once done then life becomes…See More
Jan 16

IZiel Group's Blog

Regulation and standardization of AI in healthcare

Posted on April 22, 2021 at 5:07am 0 Comments

AI Technology is making its presence in many fields now a days with advancement of IT. Medical field and specifically medical device field is also accepting that technology.

You must be aware that AI is mimicking human mind like reasoning, learning and problem solving in simple language recognising some objects, doing translation of language in truer sense and not merely word translation which is based on feed data.

Now you can imagine this great IT based technology to be used for…

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FDA Remediation Consultants

Posted on April 21, 2021 at 7:35am 0 Comments

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 [email protected] https://iziel.com/fda-remediation-consultants/

USFDA Consulting Firms

Posted on April 21, 2021 at 7:34am 0 Comments

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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FDA Remediation Consultants

Posted on April 14, 2021 at 3:19am 0 Comments

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/

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