Software as a Medical Device (SaMD) has revolutionised the healthcare industry. From AI helping with medical image scanning to software being used in apps, to help with clinical decision making. Understanding how SaMD is regulated is critical to its success when being launched as a product.
Software as a Medical Device (SaMD) Read More »
When developing a new and exciting product it can be hard to know if it might fall under specific regulations. This is usually the case with medical devices. The medical device industry is highly regulated worldwide. These regulations have specific criteria that determines if a product falls under the definition of a medical device. Therefore it is really important to evaluate your product to see if it might be in the scope of these medical device definitions for the regulation of the countries in which you wish to sell the product in.
Is My Product a Medical Device? Read More »
In today’s fast-paced and highly competitive business environment, ensuring the quality of your Medical Device products and services is paramount. Professional Quality Assurance (QA) support is the unsung hero that can help your business thrive. Whether you’re a start-up or an established enterprise, effective QA support can make a significant impact on the quality of your Management System and Devices. In this blog post, we’ll explore how professional QA support can benefit your business.
Medical Device QA Support: What are the benefits? Read More »
Medical Device Software and artificial intelligence (AI) are not just buzzwords; AI is a transformative force that is reshaping the landscape of medicine and medical technology. Over the past decade, we have witnessed remarkable advancements in AI, and its impact on the medical device industry is nothing short of revolutionary. As we step into the next five years, the synergy between AI and medical devices is poised to usher in a new era of healthcare innovation, efficiency, and patient outcomes.
Medical Device Software and AI – Revolutionizing Healthcare Read More »
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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