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Extractables & Leachables Testing: Everything You Need to Know
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. Read More
Insights
Medical Technology UK – A Show Worth Showing Up For
Medical Technology UK – A Show Worth Showing Up For Let’s be honest – picking which events to attend is tricky, in a perfect world (with an unlimited budget), we’d say yes to everything! But for 2024 and 2025,…
Q1 Moves Fast – But We Moved Faster
Building Momentum in a Cautious Market I always say Q1 is the fastest quarter of the year. People return from the holidays full of fresh energy, dust off their strategic goals, and before they’ve even hit their stride – bam,…
Net Promoter score: it’s impact on customer service
What is NPS? A Net Promoter Score NPS is a market research metric, based on a singular question asked of a company’s customers “how likely would you be to recommend our company to ….”. Using a scale of 0 to…
Test Labs MD&M West 2025 Story
MD&M West 2025 After arriving back from Arab Health, the team had a very short break before heading back out to the MD&M West event in Anaheim. This was our first US conference exhibition, and the team was excited…
Test Labs Arab Health 2025 Story
Arab Health 2025 This year we sent a team of 3 to Arab Health to walk the floor, in what is fast becoming one of the largest Med Tech conferences in the world. Conferences came thick and fast for the…
Instructions For Use
Medical Device Cleaning – Everything You Need to Know
Medical Device Cleaning Procedures Cleaning procedures are critical for medical devices as they reduce the risk of infection when being handled between uses. For this reason, cleaning procedures…
HTM 01-01: Management and decontamination of medical devices used in acute care
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…
Medical Device Manual Cleaning: Everything You Need to Know
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…
Reprocessing Orthopaedic Medical Devices: Everything You Need to Know
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…
Good Laboratory Practice & Safe Medical Device Reuse
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…
Biocompatibility
Extractables & Leachables Testing: Everything You Need to Know
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.
ISO 10993-18: Chemical Characterisation of Medical Device Materials
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…
What does ‘Knowledgeable and Experienced Professionals’ mean when choosing your BEP author
Biological Evaluation Plan: Knowledgeable and Experienced Professionals Writing a Biological Evaluation Plan (BEP) is not something that just anyone can do. It requires deep knowledge, experience, and a thorough understanding of the medical device regulatory landscape, especially if you…
Exploring the Future of Skin Irritation Testing
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…
How Design Changes Impact Biocompatibility in Medical Devices
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…
Compatibility
Material Compatibility Corrosion Testing: Everything You Need to Know
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…
Chemical Disinfectants Storage and Shelf-life Stability
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…
Medical Device Highly Accelerated Life Testing: Everything You Need to Know
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…
Handheld Device Material Compatibility – Case Study
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…
Medical Device Accelerated Aging: Everything You Need to Know
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:…
Disinfection
Bioburden Testing: Everything You Need to Know
What is Bioburden Testing? The word bioburden comes from ‘bio’ meaning life, and ‘burden’ meaning presence or load. Therefore, bioburden refers to the amount of living organisms – like bacteria or fungi- naturally present on a device. Bioburden testing is…
Medical Device Cleaning – Everything You Need to Know
Medical Device Cleaning Procedures Cleaning procedures are critical for medical devices as they reduce the risk of infection when being handled between uses. For this reason, cleaning procedures…
Total Viable Count: Everything You Need to Know
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…
Anti-Microbial Coating Testing: Everything You Need to Know
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…
Student Live Brief – Advancements in Antimicrobial Innovations for Medical Devices
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…
Electrical Safety
Medical Device Manufacturers, You Need This New Training Course: Here’s Why:
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…
Medical Device Material Compatibility – What is the impact of failure?
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…
IEC 60601-1: Everything You Need to Know
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…
You Need Pre-Compliance Evaluation – here’s why
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…
Good Laboratory Practice & Safe Medical Device Reuse
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…