Standards

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March 2024 – News Letter

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

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 »

The image shows medical devices placed on a table - This is used to indicate that Patient Guard is a Medical device regulatory and quality assurance consultancy

Understanding IEC 62304: A Guide to Medical Device Software

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 risk management of medical devices following ISO 14971

ISO 14971 and the Risk Management of Medical Devices

In the world of medical devices, ensuring both safety and compliance with industry standards is paramount. One such crucial standard is ISO 14971, a guideline that outlines the application of risk management to medical devices. In this blog post, we will delve into the significance of ISO 14971 in medical device compliance and explore how tools like Patient Guard can aid in achieving and maintaining compliance with this essential standard.

ISO 14971 and the Risk Management of Medical Devices 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

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 »

A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485?

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 »

January sign with snowflakes. Vector illustration - used for Patient Guards January medical device and IVD regulatory and Quality Assurance news letter

January 2024 News Letter

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 »

image of a card with the ISO logo on it in blue - this is used to represent content displayed by patient guard relating to medical device and IVD regulatory affairs and quality assurance as well as standards

December 2023 News Letter

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 »

image of a card with the ISO logo on it in blue - this is used to represent content displayed by patient guard relating to medical device and IVD regulatory affairs and quality assurance as well as standards

Medical Device Standards – Standards updated or issued in 2023

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

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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