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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…

Introduction Choosing the right biocompatibility standard is critical for regulatory success. ISO 10993 and ISO 18562 both assess medical device safety. But they apply to different risk pathways. Understanding their scope helps manufacturers design compliant devices, satisfy regulators, and…

What is ISO 10993-10 Skin Sensitization testing? ISO 10993-10 Skin sensitization testing assesses the possible contact of hazards from chemicals which are released from a medical…

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 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…

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.

Introduction When developing or modifying a medical device, it’s not enough to prove that it works once. You must demonstrate that it continues to perform safely and effectively throughout its entire service life. That’s where service life validation…

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…

What is a total viable count? Total viable count (TVC) is a measurement that estimates the total amount of living microorganisms in a sample, this includes bacteria, yeast or mould species. TVC counts are usually regarded as ‘non-selective’ as the…

What does FDA do? The FDA is responsible for regulating the manufacture, repackaging, relabelling and/or import of medical devices.

Introduction Medical devices are subject to rigorous testing standards in order to meet regulatory requirements…

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…

What is Corrosion? Corrosion is a natural process that occurs on metal surfaces where the metal reacts with the environment causing gradual deterioration. Oxidation reactions occur at the metal surface in the air or in water, which leads to the…

The Increasing Demand for Chemical Disinfectants It is no surprise that since the COVID-19 pandemic, there has been a surge in the disinfectant market, as manufacturers produced more and more in order to meet the increasing demand. However, this increase…

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…

Ultraviolet (UV) irradiation has been known for decades as a terminal disinfection method, widely used in a variety of applications including healthcare, agriculture, water and food treatment, as well as in airlines and many other settings. Due…

What is BS ISO 15727 standard? Disinfection via ultraviolet C (UV-C) irradiation can be fast and efficient, but to achieve this level of efficiency a high output is required (output, in this context, is the UV-C radiation power of a…

What is a total viable count? Total viable count (TVC) is a measurement that estimates the total amount of living microorganisms in a sample, this includes bacteria, yeast or mould species. TVC counts are usually regarded as ‘non-selective’ as the…

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…

Why does our Health Trust need Environmental Sampling Services? Monitoring your healthcare environment through environmental sampling is as essential to infection prevention and control (IPC) as maintaining rigorous disinfection and cleaning procedures. There are two ways in which environmental…

What is IEC 60601-1? IEC 60601 is a series of safety standards examining the safety and performance of medical electrical equipment. IEC 60601-1 is the general standard of the series: it includes the basic safety and essential performance requirements for…

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 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…

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…

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…