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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. …

Why is ISO 10993-12 Important? The ISO 10993 series set out the expected standards for medical devices that generally, come into direct contact with the patient. There are currently 23 parts to the standard that describe elements of testing depending on the…

Why does Over-Extraction Mislead Results? ISO 10993-18 defines the framework for chemical characterisation of medical devices. The intention is clear: to protect patients by identifying…

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…

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.

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 is Disinfection Validation Essential for Reusable Medical Devices? In every healthcare setting, several medical devices are utilised in the care, treatment, monitoring, and diagnosis of patients. These reusable medical devices may be used multiple times and for multiple…

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…

Why Is Medical Device Testing Essential for Approval? Medical device testing is an essential process that must be performed by all the manufacturers worldwide to…

What is Worst-Case Justification? Medical device worst-case justification is the process of identifying the most challenging to reprocess device within a product family to validate cleaning, disinfection, or sterilisation instructions. Medical device manufacturers often produce large portfolios…

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 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…

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…

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

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…

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…

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 Manual Disinfection and Why is it Important? Manual disinfection is essential for ensuring the safety of reusable medical devices that cannot undergo traditional sterilisation. It is defined as the…

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…

Do anti-microbial coating work? In the relentless pursuit of patient safety, the battle against nosocomial infections (hospital-acquired infections) has become more critical than ever. Plastics and non-porous surfaces, commonly found in medical device coatings, create an environment where bacteria…

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? 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…

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…

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…