Standards

Ensuring medical device users can operate medical devices safely and easily is of vital importance to reduce user errors IEC 62366 provides a framework for medical device manufacturers to develop safe medical devices with the user in mind.

IEC 62366-1 Usability Engineering and its use in Medical Device Design and Development

Blog, Guides and Advice, Medical Device Pre-launch, Medical Device Validation, Standards /

In medical device design, the efficacy, safety, and user experience is paramount. While the technical function of a device is unquestionably significant, its usability can often determine its real-world impact. This is where standards like IEC 62366-1 come into play, offering a structured approach to integrating user-centred design principles into the development process. In this blog, we’ll delve deeper into the significance of IEC 62366-1, its underlying principles, practical implementation strategies, and the broader implications for medical device innovation and patient care.

IEC 62366-1 Usability Engineering and its use in Medical Device Design and Development Read More »

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March 2024 – News Letter

EU Regulations, Patient Guard News, Standards /

March already! It’s starting to look like spring, the daffodils are out, it’s staying light for longer.  

This month we exhibited at the Medical Technology Exhibition at the Coventry Arena, here is our CEO and Founder David Small at our Stand.  It was lovely to meet many of our current customers and lots of potential new ones too. 

This month we have also been updating our website and our marketing content.  To keep UpToDate with the latest regulatory news and content from Patient Guard subscribe to our news letter.  You will receive a news letter email with the latest news at the beginning of the month, which is usually 2 to 3 weeks earlier than you will get it on our website news letter. 

March 2024 – News Letter Read More »

Road map relating to the extension introduced by the EU commission for the medical device regulations EU 2017/745. This road map details the new dates inline with when medical device classification types need to be in compliance with the regulation

MDR Article 120

Blog, EU Regulations, Guides and Advice, Patient Guard News, Standards /

In the fast-paced world of medical device manufacturing, regulatory standards are the bedrock of patient safety and product quality. Recently, the European Union has taken a significant step by extending Article 120 of the EU Regulation 2017/745 and EU Regulation 2017/746. This move has been made to address the mounting backlog of CE mark certifications and re-certifications within notified bodies, the entities responsible for ensuring that medical devices meet stringent quality and safety requirements before they reach the market. In this blog post, we’ll delve into the implications of this extension for medical device manufacturers and emphasize the critical importance of continued compliance.

MDR Article 120 Read More »

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Understanding IEC 62304: A Guide to Medical Device Software

Blog, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Standards /

In the ever-evolving landscape of healthcare technology, medical device software plays a pivotal role in patient care. To ensure the reliability, safety, and effectiveness of these software-driven devices, regulatory standards are in place. One such crucial standard is the IEC 62304. In this blog, we will delve into the intricacies of IEC 62304, exploring its significance, key concepts, and its impact on the development of medical device software.

Understanding IEC 62304: A Guide to Medical Device Software Read More »

the word february with red, pink and white heats exploading like confetti around it - This image is used for Patient Guards February news letter.

February 2024 – News Letter

EU Regulations, Patient Guard News, Standards /

As we step into the month of February, we at Patient Guard are delighted to extend our warmest greetings to you. We hope this newsletter finds you well and thriving in your respective endeavors. As always, we are committed to keeping you informed about the latest developments in the ever-evolving landscape of medical device regulatory affairs and quality assurance.

February 2024 – News Letter Read More »

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What is ISO 13485?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations /

ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.

Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.

Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.

What is ISO 13485? Read More »

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January 2024 News Letter

EU Regulations, Patient Guard News, Standards /

As we enter the new year, we begin planning for the upcoming year, contemplating the Regulatory and Quality Assurance requirements for Medical Devices and IVDs. In this newsletter, we provide updates from regulatory authorities and standards organizations, aiding in your planning for compliance activities.

The MHRA has unveiled a roadmap for future UK regulatory implementation, offering insights into their thought process on Medical Device and IVD Regulatory activities. The guidance outlines extended timeframes for accepting CE marked medical devices and IVDs in the UK market.

In the EU, it’s crucial to note the deadline for Manufacturers placing CE mark certified Medical Devices on the market. Those not yet transitioning to the EU MDR 2017/745 must have a contract with an EU-approved Notified Body for recertification by May 2024.

January 2024 News Letter Read More »

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December 2023 News Letter

EU Regulations, Patient Guard News, Standards /

As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year.  What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective? 

The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification – May 2024

We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.

December 2023 News Letter Read More »

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Medical Device Standards – Standards updated or issued in 2023

Patient Guard News, Standards /

Standards relating to medical devices are continually being updated and reviewed to ensure that they follow the most up to date thinking on safety and performance relating to the standards specific subject matter. Following medical device standards is a way of demonstrating that medical devices placed on the world market are safe effective and state of the art. All medical device regulations worldwide require manufacturers of medical devices to apply safety standards relevant to their medical devices.

Medical Device Standards – Standards updated or issued in 2023 Read More »

EUDAMED - European Database on Medical Devices

EUDAMED: European Database on Medical Devices

Blog, EU Regulations, Quality Management, Standards /

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. 

EUDAMED: European Database on Medical Devices Read More »

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