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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…

For successful dental instruments validation, evidence must be provided in relation to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related Instructions for Use (IFU).  Within the IFU, there must be a…

Medical Device manual cleaning If someone had told me 16 years ago that I’d still be manually cleaning items as part of my job, I’d have been quite surprised. It wasn’t so much about the cleaning itself, but more about…

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…

FDA Requirements for Reusable Medical Device Validation The FDA requires manufacturers of certain reusable medical devices to include validated instructions for use and validation data on cleaning, disinfection, and sterilization in their 510(k) premarket notifications. In this blog post, we…

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 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 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:…

Highly Accelerated Life Testing HALT HALT, or Highly Accelerated Life Testing was a term coined by Gregg K. Hobbs in 1988, describing an aggressive methodology of stress testing. It was intended to rapidly discover flaws in a device or part…

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 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…

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 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 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…

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…