LinqTo.me : Listing all Davidwaya's publicly accessible post-its

Davidwaya

Last Activity Date: Friday, April 25, 2025

Published Notes	Created:	11	Published Links	Published Folders
	Shared:	10

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Navigating Medical Device Compliance: The Role of FDA 510k, ISO 13485 ...

The medical device industry is one of the most highly regulated sectors in the world. For companies aiming to bring innovative and safe products to market, navigating compliance requirements like the FDA 510k process and achieving ISO 13485 Certification is not just ...

https://linqto.me/n/hrfv

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Davidwaya

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https://linqto.me/n/hrfu

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https://linqto.me/n/hrft

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I3CGLOBAL FDA Medical Device Registration in the USA

Introduction
The United States is home to one of the most robust and complex regulatory frameworks for medical devices in the world. Medical device manufacturers aiming to bring their products to the American market must navigate a stringent set of regulations ...

https://linqto.me/n/eohe

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Davidwaya

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Navigating EU Regulations: European Authorized Representative (EC Rep) ...

Introduction:
The European market, with its stringent regulatory environment, presents a unique set of challenges and opportunities for medical device manufacturers. To access this lucrative market, non-EU manufacturers must comply with various directives and ...

https://linqto.me/n/eltx

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Davidwaya

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UK Regulatory Consulting Services by I3CGLOBAL

I3CGLOBAL UK supports strategic regulatory affairs activities with high added value to more procedural activities aimed at obtaining authorizations quickly and efficiently, guaranteeing both the quality and safety of medicines throughout their life cycle.
Our ...

https://linqto.me/n/bysp

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Davidwaya

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510K Product Compliance Testing

The 510 (K) implementation is included in regulation 21 CFR 807 issued by the FDA. Within the scope of this agreement, the information must be presented in a regular and tabular document.
The purpose of the 510(K) product compliance tests designed by the FDA (US ...

https://linqto.me/n/azgf

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Davidwaya

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About CE Marking

Before the creation of the European Single Market, the administrations of each country had the responsibility for the compliance of products with national regulations.
In 1985, the European Single Market was created, based on achieving the free ...

https://linqto.me/n/aunh

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Davidwaya

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Biocompatibility Testing of Medical Devices – I3CGLOBAL

When materials such as PVC began to be used, exposure to phthalates was a constant concern due to its harmful effects on health. These are plasticizing substances necessary to make plastic soft, widely used in the manufacture of sexual toys.
Therefore, the health ...

https://linqto.me/n/aswj

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Davidwaya

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What Should You Know About The Medical Devices?
Every month, there are a lot of new medical devices which are submitted for the marketing approval from the FDA. One of them is the CE Marking approval which shows out the one device which will show the audience that it is purely legal and it is authorized for being a ...

https://linqto.me/n/ahdd

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Davidwaya

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