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i3cglobalblog
Last Activity Date:
Monday, January 22, 2024
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Navigating Regulatory Success: CE Mark Consultants for Medical Devices in the UK
The European Union (EU) and its regulatory framework have long been a cornerstone for medical device manufacturers aiming to bring their products to market. The CE Mark, indicating compliance with EU regulations, has been a symbol of quality and safety for medical ...
https://linqto.me/n/eojm
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i3cglobalblog
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Navigating the UK Market: The Role of Medical Device Consultants
Introduction:
The United Kingdom's medical device market is a dynamic and challenging environment, especially in the wake of regulatory changes post-Brexit. For manufacturers looking to introduce or maintain their medical devices in the UK market, ...
https://linqto.me/n/elnc
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i3cglobalblog
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CE Marking Consultant: How They Can Help Your Business
CE marking is a mandatory conformity marking for certain products sold in the European Economic Area (EEA). The CE marking indicates that a product meets the essential requirements of relevant EU Authorised Representative and regulations.
If you want to sell your ...
https://linqto.me/n/dqdw
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i3cglobalblog
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What You Should Know About the 510k Submission Process:
A blog around what you need to do to initiate a 510K submission and where to start.
When it comes to medical device development, FDA submission requirements and guidance implies device manufacturers have many pre-submission tasks to complete in order to file their ...
https://linqto.me/n/dnex
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i3cglobalblog
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I3CGLOBAL UK Responsible Person Roles & Responsibilities for medical device ...
As a UK Responsible Person for medical device registration, your role is crucial in ensuring that medical devices meet the necessary safety and quality standards before they can be placed on the market. Here are some key points on the roles and responsibilities of ...
https://linqto.me/n/dkij
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i3cglobalblog
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Guideline Relevance In Pharma Industry
Today, Regulatory Affairs is a vibrant business unit that collaborates with an emphasis to get items to the market with readily sensible label in the minimal time as well as costs. Because the enhancing global competition amongst pharmaceutical business, the ...
https://linqto.me/n/dhuw
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i3cglobalblog
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UK Responsible person – I3CGLOBAL.UK
Currently, the UK participates in the European regulatory network for medical devices, but once the transition period is over, this participation will also end. But what will remain the same and what will change?
The answers to these questions are below.
All ...
https://linqto.me/n/deoz
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i3cglobalblog
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Importance of Clinical Documentation in Clinical Trials
The medical paperwork improvement program market has turned into one of the most increasing markets as a result of the recent innovations made in the fields of biotechnology. So it is of utmost crucial to make the information basic as well as objective as it will ...
https://linqto.me/n/byjs
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i3cglobalblog
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WHAT IS THE CE DECLARATION OF CONFORMITY?
The Declaration of Conformity is the written document through which the manufacturer or its representative in the European Union declares that the marketed product complies with the essential requirements of the European Directives that apply to it.
I3CGLOBAL ...
https://linqto.me/n/ayuq
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i3cglobalblog
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New Medical Device and Product Marketing Approvals
On a monthly basis, countless new clinical devices are sent for advertising authorization from the FDA. Many of these devices are refused or re-classified, however thousands of them end up getting approved for advertising across the country. There are a number of ...
https://linqto.me/n/aukp
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i3cglobalblog
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