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Image of a file with a cog and lines above it representing text. The cog represents technical information. The image is used by patient guard limited to discuss medical device technical files (EU 2017/745).

How to Structure a Medical Device Technical File

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

A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.

In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of medical device class.

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Image of the EU flag - This image is used by Patient Guard to show their EU medical device and IVD consultancy services.

EUDAMED

Blog, EU Regulations, Patient Guard News / David Small

The EU Commission has recently announced that the transition period for completing and implementing EUDAMED has been extended again. The previous target for full functionality was the second quarter of 2024. The new target date for this is now the second quarter of 2027.

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IVD regulatory consultancy offered by Patient Guard in relation to the IVDR 2017/745

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746

Blog, EU Regulations, Guides and Advice / David Small

In the ever-evolving landscape of healthcare, in vitro diagnostic (IVD) devices are indispensable tools, providing invaluable insights into patients’ health conditions. With the introduction of Regulation (EU) 2017/746, commonly known as IVDR, the European Union has implemented stringent regulations to ensure the safety, efficacy, and quality of these diagnostic instruments. As of May 26, 2022, this regulation has ushered in a new era, shaping the practices of manufacturers, healthcare professionals, and patients as they navigate the complexities of this comprehensive regulatory framework.

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medical device consultants can help with global regulatory requirements ensuring medical device compliance

Medical Device Consultancy – Patient Guard leads the way

Blog, Patient Guard News / David Small

Medical Device Consultancy provides tailored expertise to your business, helping to navigate the medical device industry.

With advancements in technology, the need for stringent regulatory and quality assurance services has never been more crucial. In this dynamic environment, medical device consultancy plays a pivotal role, guiding innovators through the complex web of regulations, ensuring compliance, and facilitating the delivery of safe and effective devices to patients worldwide.

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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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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.

Regulating medical devices in the UK Read More »

Blog

How to Structure a Medical Device Technical File

EUDAMED

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746

Medical Device Consultancy – Patient Guard leads the way

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

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German Office

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