The main reason medical device registration is so important is safety. Ensuring that devices meet medical device regulations means that everyone involved can be confident that they are safe for their intended use. All medical devices are extremely important and can have life-saving capabilities. This means that devices must be working to their full potential.
What is the importance of medical device registration? Read More »
Quality Assurance and Quality Control are both very important factors in the Medical Device Industry. But what is Quality Assurance and Quality Control and how do they differ?
5 FAQs about Medical Device Quality Assurance vs Quality Control Read More »
Here we look at the top 3 medical device quality failures recorded in history. Do you agree with our list?
Top 3 Medical Device Quality Failures Read More »
The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic (IVDR) medical devices. It also includes the requirements for each device’s technical documentation. The information can vary based on the classification of the device, but it is always the main piece of evidence within the essential requirements.
IVD Directive Essential Requirements Checklist Read More »
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