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USFDA Regulatory Consultants

Posted by Aniket Chaudhari on April 19, 2024 at 5:00am 0 Comments

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/

MDD to MDR

Posted by Aniket Chaudhari on April 19, 2024 at 4:59am 0 Comments

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/

Configuration Management for Medical Device

Posted by Aniket Chaudhari on April 19, 2024 at 4:58am 0 Comments

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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We think the Organic Designs nap mathttps://www.biloban.com/collections/toddler-nap-mat is the best solution for families who want and all-in-one bedding and sleeping pad solution that doesn’t incorporate synthetic fabrics or harmful chemicals. All the bedding is included, making this a single solution for your child’s nap time at daycare or preschool. However, it’s also quite pricey, at least at the time of writing.
Read on to find out why we think these are the best solutions. Here are all the nap mats and all-in-one bedding solutions we considered:
Researchers have found toddler nap mats are a significant source of potentially harmful chemicals for kids in daycares and pre-schools. And that by switching from a “normal” nap mat to a non toxic nap mat, you can reduce your child’s exposure to a range of harmful chemicals.https://www.biloban.com/collections/toddler-nap-mat


In this article, we’ve identified what we think are the “safer” nap mat brands, while also providing you with some information to make your own decisions when considering the best nap mats for your child.https://www.biloban.com/collections/toddler-nap-mat
We’ve included brands that use mostly natural materials as well as those that use synthetics, provided the companies don’t add fire retardant chemicals to their mats.https://www.biloban.com/collections/toddler-nap-mat

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