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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.
Quality
eQMS: Streamlining ISO 13485 Compliance & Registration
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.
Quality
How to set up a Cleanroom for your Medical Device Industry?
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.
Europe
How to place Medical Devices in the EU, Switzerland & the UK?
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.
Quality
How to perform your Internal Audit the right way? [ISO & QSR]
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
Europe
How to place a Custom-made Medical Device on the market?
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.
Compliance
How to survive IVDR after 26 May 2022? [IVDR 2017/746]
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.
Europe
Should you start with Product Development or Document Creation?
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.
Regulatory Affairs
What is Software as a Medical Device? (SaMD) – Rule 11 MDR 2017/745
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.
Europe
How to Create a Label as per EU MDR 2017/745?
The label is an integral part of the Medical Device, So having a non-compliant label is like having a bad medical device on the market.