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What is the health technical memorandum? Health Technical Memorandum (HTM) 01-01 consists of a list of documents (part A-E) that provide guidance and information on the decontamination and reprocessing of reusable surgical instruments used in healthcare. Parts A and B…

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.

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…

Start with correct classification of your medical device Before starting the process of validating IFUs for Reusable Medical Devices, it is important to confirm correct product classification. A medical device is a healthcare product or piece of equipment that a…

Why Class Ir medical device IFU validation is important? IFU validation requirements derives from Medical Device manufacturers responsibility to maintain the integrity and cleanliness of a product and where devices are to be sterilised prior to use, minimise the risk…

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 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…

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…

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

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…

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…

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…