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Posted by Frances on April 25, 2024 at 7:29am 0 Comments

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Posted by Robert on April 25, 2024 at 7:29am 0 Comments

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Posted by George on April 25, 2024 at 7:29am 0 Comments

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Posted by Egu Marsh on April 25, 2024 at 7:26am 0 Comments

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David Waya posted a blog post

Technical Documentation & Declaration of conformity

The technical documentation is prepared based on the general safety and performance requirements set out in Annex I of the medical device’s regulation. The purpose is to document the product’s characteristics based on an assessment of the product’s quality, safety and performance.In addition, the documentation must include a clinical evaluation. A clinical evaluation is an ongoing process in…See More
Nov 22, 2022
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David Waya posted a blog post

The FDA Registration and Medical Devices

Clinical Evaluation gadgets comprise an extremely colossal and complex field. Gadgets can go from anything between a thermometer and a pacemaker. The FDA, the US' food and medication administrative body, has a definition for gadgets. It considers a clinical gadget as "an instrument, mechanical assembly, execute, machine, contraption, embed, in vitro reagent, or other comparable or related…See More
Oct 20, 2022
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David Waya posted a blog post

Do You Need to Register a Device inthe UK? Here's How:

A blog around the process and requirements of registering a medical device in the UK.If you're planning on marketing a medical device in the UK, and haven't yet familiarized yourself with the registration process for medical devices, it's time to get started.As a medical device importer or distributor located in the UK, you will have to comply with all relevant UK product regulations, including registration and listing with the Medicines and Healthcare Products Regulatory Agency (MHRA).The…See More
Sep 23, 2022
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David Waya posted a blog post

EU DECLARATION OF CONFORMITY

An EU Declaration of Conformity (also known as a Declaration of Conformity or DoC) is a mandatory document that you, as a manufacturer, must produce and sign if you manufacture, import, or distribute products for use in the EU. You must first draw up the technical documentation for the product, which includes, supports, and justifies the DoCBy drawing up and signing the EU Declaration of Conformity, the…See More
Aug 22, 2022
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David Waya posted a blog post

UKCA Certification Process – The Ultimate Guide:

a blog about how you can get recertified for the UKCA and the process.Before jumping to the process directly, first let us know what is UKCA Marking,The United Kingdom Conformity Assessment (UKCA Mark) is the UK equivalent of the EU CE Marking. This Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United kingdom conformity assessment marking is mandatory for medical devices sold in Great Britain (England, Wales, and Scotland) post …See More
Jul 20, 2022
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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, 2022
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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, 2022
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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, 2022
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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, 2022
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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, 2022
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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, 2022
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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
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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
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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
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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
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David Waya's Blog

Technical Documentation & Declaration of conformity

Posted on November 22, 2022 at 1:47am 0 Comments

The technical documentation is prepared based on the general safety and performance requirements set out in Annex I of the medical device’s regulation. The purpose is to document the product’s characteristics based on an assessment of the product’s quality, safety and performance.

In addition, the documentation must include a …

Continue

The FDA Registration and Medical Devices

Posted on October 20, 2022 at 5:13am 0 Comments

Clinical Evaluation gadgets comprise an extremely colossal and complex field. Gadgets can go from anything between a thermometer and a pacemaker. The FDA, the US' food and medication administrative body, has a definition for gadgets. It considers a clinical gadget as "an instrument, mechanical assembly, execute, machine, contraption, embed, in…

Continue

Do You Need to Register a Device inthe UK? Here's How:

Posted on September 23, 2022 at 7:22am 0 Comments

A blog around the process and requirements of registering a medical device in the UK.

If you're planning on marketing a medical device in the UK, and haven't yet familiarized yourself with the registration process for medical devices, it's time to get started.

As a medical device importer or distributor located in the UK, you will have to comply with all relevant UK product regulations,…

Continue

EU DECLARATION OF CONFORMITY

Posted on August 22, 2022 at 4:54am 0 Comments

An EU Declaration of Conformity (also known as a Declaration of Conformity or DoC) is a mandatory document that you, as a manufacturer, must produce and sign if you manufacture, import, or distribute products for use in the EU. You must first draw up the technical documentation for the product, which includes, supports, and justifies the DoC

By…

Continue

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