Blog Archives

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

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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EUDAMED: European Database on Medical Devices

Blog, EU Regulations, Quality Management, Standards / David Small

EUDAMED stands for the European Database on Medical Devices. It is a secure, web-based platform established by the EU to collect, store, and disseminate information related to medical devices available in the European market. The primary objective of EUDAMED is to centralize and harmonize data on medical devices, manufacturers, and notified bodies throughout the EU member states.

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Quality in medical devices can be divided into two areas, Quality Assurance and Quality Control in this blog we discuss the difference between the two. This image is used to represent quality, it is a clipboard with checks marks next to boxes with the words approved above it. There is a quality engineer next to it looking at a device and a spy glass over the form. On the other side of the clipboard are some boxes with barcodes on them.

Quality Assurance & Quality Control

Blog, Quality Assurance, Quality Management / David Small

Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between the two. In this blog post, we will explore the difference between medical device quality assurance and quality control.

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Medical Device Start-up

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations / David Small

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

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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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Regulating medical devices in the UK

Blog, UK Regulations / David Small

Regulating Medical Devices in the UK is slightly different to other countries. When manufacturing medical devices for the UK market, you must be registered with the MHRA. They can help to ensure that your device meets safety guidelines and issue you with advice should you need it.

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illustration of people with pencils in their hands writing on a large clipboard with the heading regulations on it - used by patient guard limited to discuss the topic of EU regulations and PRRC under article 15 in relation to medical devices and IVDS.

Person Responsible for Regulatory Compliance (PRRC)

Blog, EU Regulations, Patient Guard News / David Small

Person Responsible for Regulatory Compliance (PRRC), is a requirement for medical device and IVD manufacturers and Authorised Representative. Article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), define the legal requirements for a PRRC.

They state that each manufacturer and authorised representative (if applicable) must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.

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Photograph of medical devices including blood glucose meters, injector pens and IVD test strips

ISO 13485 Standard – Quality Management System

Blog, Quality Assurance, Quality Management, Standards / David Small

The ISO 13485 standard was built around the structure of ISO 9001 which is a standard for Quality Management Systems Requirements applied across all industry settings other than medical device companies.

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Medical Devices Classification - This is an illustration of a hand under an x-ray. The hand shows the bones of the hand. This image is used by patient guard to demonstrate an example of a class IIb medical device.

Medical Device Classification EU

Blog, EU Regulations / David Small

In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.

Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.

Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market.

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Medical Devices Classification - This is an illustration of two contact lenses. This image is used by patient guard to represent an example of class IIa medical devices.

Medical Devices Classification UK

Blog, UK Regulations / David Small

In the UK Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.

Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.

Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the UK market.

Medical Devices Classification UK Read More »

Blog

Medical Device Software and AI – Revolutionizing Healthcare

EUDAMED: European Database on Medical Devices

Quality Assurance & Quality Control

Medical Device Start-up

What is the importance of medical device registration?

Regulating medical devices in the UK

Person Responsible for Regulatory Compliance (PRRC)

ISO 13485 Standard – Quality Management System

Medical Device Classification EU

Medical Devices Classification UK

UK Office

German Office

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