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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 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…

What is biocompatibility testing, and why should I conduct these tests on my medical device? Biocompatibility testing refers to a set of standards (ISO-10993) that defines the potential biological risks of a device upon encountering the human body, specifically evaluating…

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…

In the medical device industry, patient safety and regulatory compliance are non-negotiable. One critical step in ensuring both is understanding which chemical substances may be released from a device during storage, handling, or clinical use. This is where Extractables and Leachables (E&L) testing comes in — a process governed by ISO 10993-18, the international standard for the chemical characterisation of medical device materials.

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 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…

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…

Real-World Challenges in Reprocessing Imagine a crucial step in patient safety being overlooked. That’s often the reality for sterile processing departments (SPD). Without proper inclusion and clear communication, the risk of improper reprocessing skyrockets, putting patients in harm’s way…

What is a medical device technical file? The EU 2017/745 Medical Device Regulation (MDR) requires that manufacturers of medical devices produce and maintain a technical file for each of their devices. The intent of this article is to broadly…

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…

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 Medical Device accelerated aging? Aging refers to the process by which properties of a product change over time. Aging studies are used to determine how a product behaves under normal storage/use conditions over long periods of time:…

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…

The COVID-19 influence on cleaning practices As we are all aware, the consequences of the COVID-19 pandemic were wide-ranging and varied. In the world of medical devices, one impact in particular has been frequently overlooked: a pronounced increase in the…

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 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 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…

Live Briefs at Anglia Ruskin University At ARU, Live Briefs play a key role in course assessment and teaching methodology. These briefs offer students a valuable opportunity to apply their theoretical knowledge to real-world scenarios, helping them better prepare…

The importance of the EN 17272 test Healthcare-associated infections (HCAIs) are one of the biggest threats to the healthcare system. These infections are usually acquired after hospitalisation and manifest 48 hours after admission to the hospital. These infections 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…

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…

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…

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…