David Waya
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David Waya posted a blog post

What is an European Authorized Representative?

The European Authorized Representative is represented on the medical device label with a logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an EU Rep / EC Rep, the manufacturer must sign a contract outlining each party’s rights and responsibilities,…See More
Jun 17
David Waya posted a blog post

How Do I Choose the Best in UDI for Medical Devices?

A blog about ultrasound device identification and guidelines.Ultrasound device identification (UDI) is an FDA compliance that all medical device manufacturers must adhere to. UDI labels are affixed to medical devices that use ultrasound and is used for tracking purposes in hospitals in case of emergencies.What is UDI?UDI stands for Unique Device Identification. According to the Food and Drug Administration website, "UDI is a system that assigns a unique identifying label to each device; the…See More
May 20
David Waya posted a blog post

Is Clinical Evaluation Necessary?

How to Know When It is: A blog about clinical trials, the science behind them and how you can get involved.Clinical trials are studies that involve humans. They are used to test different medical treatments like drugs, vaccines, or medical devices. Find out more about clinical evaluation, the science behind it and how you can get involved.If…See More
Apr 22
David Waya posted a blog post

How to obtain a health registration

The activity of your company will determine if you should apply to join the registry.Once you have been registered in it, you must keep the health authorities up to date on any change in the ownership and physical address of your company, in the characteristics of your products and in the manufacturing processes.You must also notify them when you discontinue the manufacture or sale of a product for which you had authorization.The request is made in the Administration of the corresponding…See More
Mar 22
David Waya posted a blog post

Medical Device Technical File and Post-Marketing Surveillance

The technical file is a collection of information and documents that describe in detail the medical device under consideration and in particular the aspects related to the safety and efficacy of the product, starting from the design phase up to post-marketing surveillance.The technical file also describes all the possible solutions taken by the…See More
Feb 21
David Waya posted a blog post

I3CGLOBAL FDA Registration Services

I3CGLOBAL Group help food, alcohol, dietary supplement, cosmetic, and medical device companies comply with FDA requirements and regulations. The main purposes of "pre-compliance" assistance are to ensure that your product is marketable in the United States, before entry, and to avoid timely and costly delays.Pre-compliance assistance includes product and label review, US agent services for the registration of foreign food facilities with the FDA, and potential registrations with the…See More
Jan 28
David Waya posted a blog post

What’s New in The European Authorized Representative Regulation?

What’s New in The European Authorized Representative Regulation?This new regulation will affect all companies that sell CE-marked products manufactured outside the European Union. As the Brexit transition period is over, this includes UK-made products, but also e-commerce and e-business companies like Amazon. Therefore, resellers of CE-marked products should make sure that their suppliers have made the necessary arrangements for the…See More
Aug 2, 2021
David Waya posted a blog post

What is an EU Representative?

Once the Brexit transition period ends, organizations based in the UK trade with the European Union will be required to appoint an European Authorized Representative.What is an EU representative? A legal entity established in the EU serves as a point of contact between your organization, supervisory authorities, and data subjects. Facilitate communications between your organization and EU supervisory authorities in…See More
Feb 13, 2021
David Waya posted a blog post

Regulation Importance In Pharma Industry

Today, Regulatory Matters is a vibrant organization unit that works with an emphasis to obtain items to the marketplace with commercially feasible label in the minimal time and also costs. Because the increasing global competitiveness amongst pharmaceutical business, the trick to success depends on getting prompt advertising approval from the Regulatory Matters of the region where the drug is to be sold. Numerous federal government companies are involved in regulating medications within their…See More
Jan 2, 2021
David Waya posted a blog post

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 medical device. Most of these devices are firstly turned down or they are also re classified some of the times, but hundreds and thousands of them ended up in getting the approval for marketing it nationwide. You should also do…See More
Sep 30, 2020
David Waya posted photos
Jun 22, 2020
David Waya posted a photo

Medical Device Technical File

I3CGLOBAL provide a MDR 2017 / 745 Annex II medical device technical file (MDR) and technical documentation is a summary document prepared by the manufacturer in a clear, well.For more related information visit a website.…
Jun 8, 2020
David Waya posted a photo

Medical Device Consultants

I3CGLOBAL provide a bunch of Medical Device Regulatory Professionals for ready for your service. We have a experience team that are provide a services for our valuable customers. Visit Now for more!…
May 22, 2020
David Waya posted a photo

Medical Device Technical File

I3CGLOBAL provide a MDR 2017 / 745 Annex II medical device technical file (MDR) and technical documentation is a summary document prepared by the manufacturer in a clear, well.For…
May 9, 2020
David Waya posted a blog post

What is the CE Marking and its application on Medical Devices?

The European Conformity Marking (CE) is the procedure by which a manufacturer (or importer) reports that the product to be marketed in the European Union meets the essential health and safety requirements defined in the mandatory legislation.It is one of the basic pillars of the European Union for the free movement of goods, which helps to create an Internal Market favorable to development and wealth creation.Consequences of this requirement:The CE Marking represents an opportunity for…See More
May 2, 2020
David Waya posted a photo

CE Marking for Medical Devices

I3CGLOBAL provide a Medical Device CE Marking service covering reusable medical devices, equipment, disposables, implants, drug-device combination, and home healthcare devices and more.visit a website and know more.…
Apr 27, 2020

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David Waya's Blog

What is an European Authorized Representative?

Posted on June 17, 2022 at 8:32am 0 Comments

The European Authorized Representative is represented on the medical device label with a logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an EU Rep / EC Rep, the manufacturer must sign a contract outlining each…

Continue

How Do I Choose the Best in UDI for Medical Devices?

Posted on May 20, 2022 at 4:21am 0 Comments

A blog about ultrasound device identification and guidelines.

Ultrasound device identification (UDI) is an FDA compliance that all medical device manufacturers must adhere to. UDI labels are affixed to medical devices that use ultrasound and is used for tracking purposes in hospitals in case of emergencies.…

Continue

Is Clinical Evaluation Necessary?

Posted on April 22, 2022 at 3:07am 0 Comments

How to Know When It is: A blog about clinical trials, the science behind them and how you can get involved.

Clinical trials are studies that involve humans. They are used to test different medical treatments like drugs, vaccines, or medical devices. Find out more about clinical evaluation, the science behind it and how you can get involved.…

Continue

How to obtain a health registration

Posted on March 22, 2022 at 4:25am 0 Comments

The activity of your company will determine if you should apply to join the registry.

Once you have been registered in it, you must keep the health authorities up to date on any change in the ownership and physical address of your company, in the characteristics of your products and in the manufacturing processes.

You must also notify them when you discontinue the…

Continue

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