Standards

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The Biological Evaluation of Medical Devices

In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life.  Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device’s interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process.

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CE Marking Medical Devices

The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745 for medical devices and EU 2017/746 for IVDs) to lawfully place medical devices on the EU market. Manufacturers must affix the CE mark on the medical device or IVD itself and on the primary packaging (or just on the packaging if affixing to the device itself it not possible). The CE mark should also be placed on any instructions for use and any labelling. The use of the CE mark identifies that a medical device or IVD conforms to EU regulatory requirements and is a symbol that a device meets safety standards.

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Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy

Medical Device Consultancy Companies

A medical device consultancy is a firm that offers specialized services for companies involved in the development, manufacturing, and marketing of medical devices. These consultancies typically have teams of experts who provide a wide range of services, from regulatory strategy to product development, quality management systems (QMS), and market access.

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Skin Irritation Testing

In Vitro Skin Irritation Testing: ISO 10993-23 Standard

Skin irritation occurs when a substance causes inflammation or damage to the skin upon contact. For medical devices, this can be a serious concern, as they are often in prolonged contact with the skin. The consequences of not adequately testing for irritation can range from minor redness to severe dermatitis, leading to discomfort, injury, or even infection in users. Therefore, reliable testing methods are crucial to ensure that products are safe before they reach the market.

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Cytotoxicity Testing in Medial Devices ISO 10993-5

Cytotoxicity Testing in Medical Device Biological Evaluation

In the highly regulated world of medical devices, ensuring patient safety is paramount. One of the essential components of this safety assurance is cytotoxicity testing, specifically adhering to ISO 10993-5 standards. This blog explores the importance of ISO 10993-5 cytotoxicity testing, particularly for medical devices that come into direct contact with patients, and how it contributes to the overall safety and efficacy of these devices.

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E&L Testing in medical devices

Extractables and Leachables Testing for Medical Devices in ISO 10993

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.

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Core elements that make up quality management systems

Understanding the core elements of Quality Management Systems

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

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.

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April 2024 – News Letter

As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.

We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information.

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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

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.

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