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We help you under EU Technical Documentation
Technical Documentation per EU MDR is built as per annex II and annex III. Now you can create the technical documentation in very easy manner.
We can help you build your complete Quality Management System for Medical Devices and even include our eQMS SmartEye
We will help you register your products all over the world with the support of our team and network. We cover also MDSAP, EU MDR, IVDR, FDA, Middle East...
We can audit your company to comply with the internal audit requirement or audit your suppliers that you need to integrate on your Approved Supplier List. We can also execute Mock Inspection to test your company and be prepared for the real audit.
You are in the process to design and develop a Medical Device? Then hire us to help you follow the requirements of the regulation from the beginning and not to have to redo that when the product will be already finished as this can cost you more money
We have offices in EU, Switzerland and UK where we can become your Authorized Representatives. This is mandatory if your company is not located in these regions.
We are also offering the service of Importer for EU and Switzerland where we will execute all the inspections needed per the regulation and record all those elements on our files. An attestation of release will be provided to you as a proof that your product passed all the checks.
I am delighted with Easy Medical Device's expertise in preparing a flawless Technical File for MDR compliance. Their professionalism, and clear communication helped us to navigate the complex realm of medical device regulations. The project was completed within the stipulated timeframe, showcasing their commitment to delivering results promptly without compromising on quality. I wholeheartedly endorse Easy Medical Device for its exceptional services.
Technical Documentation per EU MDR is built as per annex II and annex III. Now you can create the technical documentation in very easy manner.
You need an eQMS but why. Let me tell you on this article why this is important and let me also help you on that. Contact us at the end if you are needing support.
Maybe you are thinking of building a cleanroom for your Medical Device industry. Then read that first to have a clear understanding of how much this cost and also all the maintenance to perform.
Placing a devicec in the EU, UK and Switzerland can start to be complicated with what is happening in the region with Brexit, Swixit and the issuance of new legislations. Let's look at that.
Internal audit is a tool that is available within ISO 13485 or QSR 21 CFR part 820. We will explain how to perform it the right way
There are many categories of Medical Devices but this one is really special. You can market it very quickly without to wait for a lot of studies and more importantly, it's a unique product only made for 1 person and this is the Custom-Made Medical Device.
IVDR is the new In-Vitro Diagnostic Regulation for the European Union. So what should you expect from it? How can you be ready? What are the elements to take care of? I will tell you everything on this podcast.
This is a good question. Should we first focus on documents creation or should we focus on our prototypes. This is something that we discuss on this article.
A Software as a Medical Device (SaMD) is really a specific kind of medical device. I teach you on this article all that you need to follow to put it on the market. I developed a 3 step program to put any medical device on the market. The Route Plan. You need to plan all before to start your journey. Follow the Medical Device Regulation MDR 2017/745 that should be in place before 25 May 2020.