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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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Medical Device QA Support: What are the benefits?

Blog, Client Questions /

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 »

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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 »

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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 »

global medical device and IVD registrations.

Medical Device & IVD registration

Blog, EU Regulations, UK Regulations, USA Regulations /

Medical device registration is an essential part of commercialising your medical device or IVD.  First requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. 

Medical Device & IVD registration Read More »

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 /

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.

How to Structure a Medical Device Technical File Read More »

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 /

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.

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

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 /

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.

Medical Device Consultancy – Patient Guard leads the way Read More »

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Medical Device Software and AI – Revolutionizing Healthcare

Blog, Client Questions /

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.

Medical Device Software and AI – Revolutionizing Healthcare Read More »

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