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Is My Product a Medical Device?

Leave a Comment / Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, UK Regulations, USA Regulations / David Small

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.

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The image shows a digital screen with light up in blue against a dark background are icons such as a tick, and a pad with a pencil next to it. The icons are in hexagons. In other light up hexagons are the words Quality Assurance . This image is used by Patient Guard to talk about their Medical Device and IVD Quality Assurance Services.

Medical Device QA Support: What are the benefits?

Blog, Client Questions / David Small

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.

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Medical Device Software and AI – Revolutionizing Healthcare

Blog, Client Questions / David Small

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.

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Image shows a Doctor in green scrubs with folded arms - This image is used by Patient Guard to describe its medical device and IVD regulatory and quality assurance related content.

What is the importance of medical device registration?

Blog, Client Questions, EU Regulations, UK Regulations, USA Regulations / David Small

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.

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Image of cola bottles being processed along a production line - This image is used by Patient Guard to describe Quality Control.

Quality Assurance vs Quality Control

Blog, Client Questions, Quality Assurance / David Small

Quality Assurance (QA) vs Quality Control (QC) is a commonly asked question but both are important aspects of Quality Management Systems (QMS). They work side by side but the two are defined differently. It is common for these two terms to be used interchangeably, however, there are distinctive differences between the two. QA manages the

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Top 5 quality management system failures

Blog, Client Questions, Guides and Advice, Quality Management / David Small

In this blog, we will discuss some of the (in our opinion) top 5 quality management system-related failures. These failures had massive consequences, including loss of life and financial impact, for the companies and organisations involved. Hopefully, by the end of the blog, you should also have a good understanding of why having a quality

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In vitro diagnostic regulations (IVDR), patient guard is a leading IVD consultancy

IVD Directive Essential Requirements Checklist

Blog, Client Questions, USA Regulations / David Small

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.

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Client Questions

Is My Product a Medical Device?

Medical Device QA Support: What are the benefits?

Medical Device Software and AI – Revolutionizing Healthcare

What is the importance of medical device registration?

Quality Assurance vs Quality Control

Top 5 quality management system failures

IVD Directive Essential Requirements Checklist

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