Welcome to Outlook, medical device, healthcare & medtech news, articles & opinions from leading industry experts - available in-print & online

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…

What is Chemical Characterisation? Chemical characterisation involves analytical techniques that determine the identity and quantity of the chemical components of a material. It is important to know what chemicals are present in a medical device, as well as in the…

What is biological evaluation plan? Biological evaluation plan is a risk management activity in which manufacturers consider possible biological hazards and risks associated with the clinical use of the device. The process of evaluating the biocompatibility of a device is…

Biological Evaluation Plan: Knowledgeable and Experienced Professionals Writing a Biological Evaluation Plan (BEP) is not something that just anyone can do. It requires deep knowledge, experience, and a thorough understanding of the medical device regulatory landscape, especially if you…

Understanding the Role of Chemical Characterisation in Medical Devices Analytical chemistry was something that during my studies in Medicinal Chemistry, I assumed was largely applicable to the field of pharmaceuticals in drug discovery as well as in formulation…

Reusable orthopaedic surgical equipment Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients such as orthopaedic surgical equipment. Medical devices intended for reuse are likely to be contaminated with patient tissue or…

What Remains After Sterilisation and Why Does Residual Hydrogen Peroxide Matter? If you’ve ever worked in a lab long enough, you’ll know that the smallest details often carry the biggest weight. I was reminded of this recently while reviewing…

Medical Device Cleaning Procedures Cleaning procedures are critical for medical devices as they reduce the risk of infection when being handled between uses. For this reason, cleaning procedures…

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 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…

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…

Introduction  In the ongoing battle against infections, surface material compatibility often goes unnoticed, yet it significantly impacts both patient and healthcare provider safety. …

What Is Quality Testing in Medical Devices and Why Does it Matter?  When people think of medical devices, they often picture the final product – sleek, sterile, and ready for use. But behind every safe and effective…

What is material compatibility? Medical device safety testing includes material compatibility studies. Material compatibility is determining the resistance between a surface (or product) and disinfectant products and technologies. An adverse reaction resulting in incompatibility of different components can impact 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.

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 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 ultraviolet C irradiation? Ultraviolet C (UV-C) irradiation is an effective means of disinfection, but it is also a potential health risk. Exposure to UV-C radiation can potentially cause a number of health issues, particularly to the skin and…

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…

Hydrogen peroxide vapour (HPV), as we know it, has been employed for decades in bio-decontamination technology systems to decontaminate hospitals and decrease rates of hospital-acquired infections. HPV was shown to kill microorganisms by interacting with their lipid membranes and disturbing…

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…

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…

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…

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…

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…