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What is Cytotoxicity in Medical Devices? Cytotoxicity refers to the potential of a substance or material to cause damage to living cells. In the context of medical devices, cytotoxicity testing is a critical part of the biocompatibility evaluation…

Why Medical Device Design Changes Matter The ISO 10993-1 standard outlines scenarios where a biocompatibility reassessment is necessary after a design change: 1. Material Changes: Switching materials or modifying formulations can affect how a device interacts…

This article explores cytotoxicity testing, a critical step in assessing the biocompatibility of medical devices. It explains how cytotoxicity studies are conducted using in vitro methods to evaluate whether materials used in a device cause cell damage or death.

Exploring the Future of Skin Irritation Testing: Our Visit to MatTek Corporation in Bratislava Our team – Enrico, Riwia, and Sophie – attended a training session in Bratislava, Slovakia. Our destination was MatTek Corporation, where we participated…

Why Biocompatibility Matters in Medical Devices In medical devices, innovation often takes the spotlight. Shiny new materials, novel coatings, and futuristic 3D-printed structures attract attention. But behind every device that actually reaches patients lies an unsung hero: biocompatibility. …

What are General Surgical Instruments? “General” in this context doesn’t necessarily mean that general surgical instruments are used in all forms of surgery, but instead refers to a surgical specialty that mostly focuses on the contents of the abdomen. Each…

For successful dental instruments validation, evidence must be provided in relation to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related Instructions for Use (IFU).

Chemical indicators have been used for decades to validate sterilisation and decontamination parameters and to ensure that the process has met the standard required for such procedures. However, there aren’t many published materials on their efficacy in delivering or providing…

What is a Medical Device ‘Instructions for Use’? ‘IFU’ stands for Instructions for Use, and it is an acronym that is a common buzzword heard in the medical device field. In its most basic definition, an IFU…

FDA Requirements for Reusable Medical Device Validation The FDA requires manufacturers of certain reusable medical devices to include validated instructions for use and validation data on cleaning, disinfection, and sterilization in their 510(k) premarket notifications. In this blog post, we…

Medical Device Material Performance To prevent the spread of healthcare-associated infections (HAIs), it is vital that surfaces and devices used in healthcare settings undergo disinfection/sterilisation. However, a growing problem is failure and damage to medical devices due to incorrect cleaning…

Medical Devices: Are they compatible with IPC? As a medical device manufacturer, your products contribute towards the treatment, care and recovery of millions of people around the world. But while they are designed to function reliably, many medical devices are…

What is barcode verification? Barcode verification is a process in which 1-D and 2-D barcodes are graded according to specific quality parameters defined by the industry. With technologies advancing and regulations changing, verification is becoming a fundamental step to…

What is IEC 60601-1? First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the…

Live Briefs at ARU At ARU, Live Briefs are an integral part of the course assessment and an essential aspect of teaching. They offer students a chance to apply their knowledge to current issues, preparing them for future employment.

Photobiology is a field of science that has been around since ancient times, however, the technology used to understand the effect of light on organisms has grown exponentially over the centuries. So, what is photobiology? Broadly speaking, photobiology is a…

What does ATP stand for? ‘Mitochondria is the powerhouse of a cell’ is a phrase that should be engrained from many science lessons in school, but what exactly gives the mitochondria its power-like abilities? The answer is an intracellular small…

A mode of action describes a functional or anatomical change, resulting from the exposure of a living organism to a substance. Different biocides have a different mode of action and therefore work differently to destroy the living substance. Disinfectants are…

What classification of medical device is my disinfectant? Annex VIII of the EU 2017/745 Medical Device Regulation (MDR) outlines the classification rules for medical devices. Application of these classification rules should be determined by the intended use of the device.

What is Bioburden Testing? The word bioburden comes from ‘bio’ meaning life, and ‘burden’ meaning presence or load. Therefore, bioburden refers to the amount of living organisms – like bacteria or fungi- naturally present on a device. Bioburden testing is…

What is Good Laboratory Practice? Good Laboratory Practice (GLP) refers to a set of principles designed to be implemented within a testing facilities quality management system. These principles define the processes and conditions under which non-clinical health and environmental safety…

Laboratory Training Course for Medical Device Manufacturers We have been listening to our client feedback, and in response to market need, Lorit Consultancy and Test Labs have co-developed a laboratory training course specifically designed for medical device manufacturers. This course…

Medical Devices: Are they compatible with IPC? As a medical device manufacturer, your products contribute towards the treatment, care and recovery of millions of people around the world. But while they are designed to function reliably, many medical devices are…

What is IEC 60601-1? First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the…

Why Does Electrical Safety Matter in Medical Technology? Electrical safety is of the utmost importance in medical technology because medical devices, which range from simple diagnostic tools to complex life support systems, interact directly with patients and medical personnel. One…