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5 test tubes with green, yellow, red, purple and blue coloured liquid to make a rainbow. Used by patient guard to represent biological evaluation services.

The Biological Evaluation of Medical Devices

Leave a Comment / Blog, EU Regulations, Guides and Advice, Medical Device Validation, Standards, UK Regulations, USA Regulations /

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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is my product a medical device?

Is My Product a Medical Device?

Leave a Comment / Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, UK Regulations, USA Regulations /

When developing a new and exciting product it can be hard to know if it might fall under specific regulations. This is usually the case with medical devices. The medical device industry is highly regulated worldwide. These regulations have specific criteria that determines if a product falls under the definition of a medical device. Therefore it is really important to evaluate your product to see if it might be in the scope of these medical device definitions for the regulation of the countries in which you wish to sell the product in. 

Is My Product a Medical Device? Read More »

Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy

Medical Device Consultancy Companies

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

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

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

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.

In Vitro Skin Irritation Testing: ISO 10993-23 Standard Read More »

Cytotoxicity Testing in Medial Devices ISO 10993-5

Cytotoxicity Testing in Medical Device Biological Evaluation

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

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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drug Infusion bag

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 /

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.

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

E&L Testing in medical devices

Extractables and Leachables Testing for Medical Devices in ISO 10993

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

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

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

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 /

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 »

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