Client Questions Archives

Is My Product a Medical Device?

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.

Medical Device QA Support: What are the benefits? Read More »

image of a spy glass looking at graphs of data - image indicates patient guard as a medical device and IVD regulatory and quality assurance consultancy, with services such as post market surveillance.

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.

What is the importance of medical device registration? Read More »

medical device quality control and quality assurance

5 FAQs about Medical Device Quality Assurance vs Quality Control

Blog, Client Questions, Quality Assurance / David Small

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?

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Top 3 Medical Device Quality Failures

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

Here we look at the top 3 medical device quality failures recorded in history. Do you agree with our list?

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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.

IVD Directive Essential Requirements Checklist Read More »

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?

5 FAQs about Medical Device Quality Assurance vs Quality Control

Top 3 Medical Device Quality Failures

IVD Directive Essential Requirements Checklist

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