Blog Archives

Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags

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

Ensuring the stability of drugs in contact with medical devices such as syringes, infusion administration sets and infusion administration bags is paramount. This article delves into the importance of drug stability testing, the challenges faced, and the methodologies employed to guarantee that the drugs administered through these devices remain safe and effective.

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Extractables and Leachables Testing for Medical Devices in ISO 10993

Blog, EU Regulations, Medical Device Pre-launch, Medical Device Validation, Standards, USA Regulations / David Small

In medical device design and development and manufacturing, ensuring the safety and biocompatibility of products is paramount. As part of the biological evaluation process, extractables and leachables (E&L) testing plays a crucial role. This testing ensures that any chemicals that might migrate from the device materials into the body do not pose a risk to patients. The ISO 10993 standard series provides comprehensive guidelines for the biological evaluation of medical devices, including protocols for E&L testing. In this blog, we will delve into the importance of extractables and leachables testing, its procedures, and its relevance within the ISO 10993 framework.

Extractables and Leachables Testing for Medical Devices in ISO 10993 Read More »

Core elements that make up quality management systems

Understanding the core elements of Quality Management Systems

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

In today’s competitive marketplace, delivering high-quality products and services is essential for business success. A Quality Management System (QMS) is a structured framework that helps organizations ensure they meet customer requirements and enhance customer satisfaction. But what are the fundamental elements that constitute a robust QMS? In this blog, we will explore the basic components that form the backbone of effective quality management systems.

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FDA update of QSR to be inline with ISO 13485 for harmonisation.

5 Differences Between ISO 13485 & FDAs Medical Device QSR

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

Medical device manufacturers face a daunting task: navigating complex regulatory landscapes to ensure their products meet safety and quality standards. In order to sell products in the US, manufacturers are required to comply with CFR 21 Part 820, whereas for global markets, the voluntary ISO 13485 is used. These two standards are not the same, and companies must understand the differences between them if they are to get their products to market across regions. However, with the FDA actively working to align CFR 21 Part 820 more closely with ISO 13485, the effort toward global harmonization is a promising sign for medical device manufacturers.

5 Differences Between ISO 13485 & FDAs Medical Device QSR Read More »

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 / David Small

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 »

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 / David Small

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 a digital screen with light up in blue against a dark background are icons such as a tick, and a pad with a pencil next to it. The icons are in hexagons. In other light up hexagons are the words Quality Assurance . This image is used by Patient Guard to talk about their Medical Device and IVD Quality Assurance Services.

Medical Device QA Support: What are the benefits?

Blog, Client Questions / David Small

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 »

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

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

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 »

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?

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 / David Small

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 / David Small

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 »

Blog

Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags

Extractables and Leachables Testing for Medical Devices in ISO 10993

Understanding the core elements of Quality Management Systems

5 Differences Between ISO 13485 & FDAs Medical Device QSR

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

MDR Article 120

Medical Device QA Support: What are the benefits?

Understanding IEC 62304: A Guide to Medical Device Software

What is ISO 13485?

Medical Device & IVD registration

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