Welcome to Outlook, the digital home of our popular industry annual

Get resources & industry updates direct to your inbox

We’ll email you 1-2 times a week at the maximum and never share your information

Latest

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, Q1 is gone. That’s why we approach Q1 with urgency… Read More

News

Test Labs Team People Behind the Progress: Growth in the Test Labs Team
Test Labs Successfully Completed ISO 17025 UKAS Reassessment
Test Labs Successfully Completed BSI Stage 2 Assessment Audits
Student Live Brief – 2025 Kick off session

Popular Articles

Scaling Up: Test Labs Invests £250,000 in New Laboratory Facilities FDA Medical Device requirements: Everything You Need to Know The Unseen Cost: Why Medical Device Companies Can’t Ignore Regulatory Budgeting Extractables & Leachables Testing: Everything You Need to Know

Insights  

Medical Device Expert Spotlight – Holly Scott Image
Medical Device Expert Spotlight – Holly Scott Image
Medical Device Expert Spotlight – Holly Scott Image

Medical Device Expert Spotlight – Holly Scott

Medical Device Expert Spotlight At Test Labs, our greatest strength lies in our people – their expertise, dedication, and passion form the foundation of our success. In this edition of Expert Spotlight, we’re excited to introduce Holly, our Executive Assistant…
By: Test Labs,
BS EN ISO 15858
BS EN ISO 15858
BS EN ISO 15858

BS EN ISO 15858: Human Exposure Limits to UV-C

Disinfection systems utilising ultraviolet C (UV-C) irradiation are becoming more and more common, but this increased usage can lead to an increased risk of harmful exposure to UV-C radiation. UV-C exposure can lead to some unpleasant health issues, particularly in…
By: James Tolmie, Laboratory Scientist
Medical Device Events 2025 Image
Medical Device Events 2025 Image
Medical Device Events 2025 Image

Medical Device Events 2025

Medical Device Events Test Labs Will Attend in 2025 2025 is shaping up to be an exciting year for the medical device industry, and part of that success lies in being at the right events. We know that real progress…
By: Tautvydas Karitonas, MD
Test Labs MD&M West 2025 Story Image
Test Labs MD&M West 2025 Story Image
Test Labs MD&M West 2025 Story Image

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…
By: Marianne Browning, Business Development
Surgical instrument IFU validation requirements
Surgical instrument IFU validation requirements
Surgical instrument IFU validation requirements

General Surgical Instruments: Everything you need to know

What are General Surgical Instruments? “General” in this context doesn’t necessarily mean that general surgical instruments are used in all forms of surgery, but instead refers to a surgical specialty that mostly focuses on the contents of the abdomen. Each…
By: James Tolmie, Laboratory Scientist
How to lose out on grant funding by 2% – Case Study Image
How to lose out on grant funding by 2% – Case Study Image
How to lose out on grant funding by 2% – Case Study Image

How to lose out on grant funding by 2% – Case Study

How to lose out on grant funding by 2% – common mistakes In the fiercely competitive world of grants, losing out on funding is not uncommon, in fact the odds are largely against you.  Only 5% of applicants on average…
By: Eleanor Barnes, Grant Funding
Medical device CE mark
Medical device CE mark
Medical device CE mark

How to CE mark a Medical Device

To obtain medical device CE mark and place a medical device on the market in the EU, manufacturers must now demonstrate conformity with the EU 2017/745 Medical Device Regulation (MDR) which has replaced the previous Medical Device Directive 93/42/EEC (MDD)…
By: Toni Carlton, Head of Q&C

Instructions For Use  

Good Laboratory Practice & Safe Medical Device Reuse Image
Good Laboratory Practice & Safe Medical Device Reuse Image
Good Laboratory Practice & Safe Medical Device Reuse Image

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…
By: Toni Carlton, Head of Q&C
Dental instrument validation case study
Dental instrument validation case study
Dental instrument validation case study

Dental instrument IFU validation in under 4 weeks – Case study

Dental instrument IFU validation Test Labs was contracted out to test and evaluate the instructions for use (IFU) of a re-processable dental medical device (MD) as required by ISO 17664-1:2021 “Processing of health care products — Information to be provided…
By: Chris Sibanda, Study Manager
Medical device Class Ir testing at TestLabs
Medical device Class Ir testing at TestLabs
Medical device Class Ir testing at TestLabs

Technical file requirements for Class Ir: Everything you need to know

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…
By: James Tolmie, Laboratory Scientist
Surgical instrument IFU validation requirements
Surgical instrument IFU validation requirements
Surgical instrument IFU validation requirements

IFU validation requirements for Class Ir Medical Devices

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…
By: Toni Carlton, Head of Q&C
Medical Device Barcode Verification
Medical Device Barcode Verification
Medical Device Barcode Verification

Medical Device Barcode Verification: Everything You Need to Know

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…
By: Toni Carlton, Head of Q&C

Biocompatibility  

What does ‘Knowledgeable and Experienced Professionals’ mean when choosing your BEP author Image
What does ‘Knowledgeable and Experienced Professionals’ mean when choosing your BEP author Image
What does ‘Knowledgeable and Experienced Professionals’ mean when choosing your BEP author Image

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…
By: Marianne Browning, Business Development
Test Labs - Plate Reader
Test Labs - Plate Reader
Test Labs - Plate Reader

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.
By: Syeda Begum, Laboratory Scientist
Biological Evaluation Plan: Everything You Need to Know Image
Biological Evaluation Plan: Everything You Need to Know Image
Biological Evaluation Plan: Everything You Need to Know Image

Biological Evaluation Plan: Everything You Need to Know

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…
By: Sophie Bell, Study Manager
Cytotoxicity Testing
Cytotoxicity Testing
Cytotoxicity Testing

Cytotoxicity Testing: Everything You Need to Know

This article explores cytotoxicity testing, a critical step in assessing the biocompatibility of medical devices. It explains how cytotoxicity studies are conducted using in vitro methods to evaluate whether materials used in a device cause cell damage or death.
By: Riwia Chetian, Laboratory Scientist
How Design Changes Impact Biocompatibility in Medical Devices Image
How Design Changes Impact Biocompatibility in Medical Devices Image
How Design Changes Impact Biocompatibility in Medical Devices Image

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…
By: Sophie Bell, Study Manager

Compatibility  

Medical Device Safety Testing - Test Labs
Medical Device Safety Testing - Test Labs
Medical Device Safety Testing - Test Labs

Medical Device Safety Testing – MDR focus on material compatibility

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…
By: Toni Carlton, Head of Q&C
Handheld Device Material Compatibility – Case Study Image
Handheld Device Material Compatibility – Case Study Image
Handheld Device Material Compatibility – Case Study Image

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…
By: James Tolmie, Laboratory Scientist
Material Compatibility Corrosion Testing
Material Compatibility Corrosion Testing
Material Compatibility Corrosion Testing

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…
By: Syeda Begum, Laboratory Scientist
You Need Pre-Compliance Evaluation – here’s why Image
You Need Pre-Compliance Evaluation – here’s why Image
You Need Pre-Compliance Evaluation – here’s why Image

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…
By: James Tolmie, Laboratory Scientist
Test Labs Uk Medical Device Testing Facility.
Test Labs Uk Medical Device Testing Facility.
Test Labs Uk Medical Device Testing Facility.

FDA Medical Device Material Performance Requirements – Guide

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…
By: Syeda Begum, Laboratory Scientist

Disinfection  

BPR
BPR
BPR

What are the biocide regulations?

What is a biocide? A biocide is a chemical substance or microorganism which intention is to “control any harmful organism in a way that is not purely physical or mechanical”. They are commonly used as disinfectants, oxidising agents, insect repellents…
By: Toni Carlton, Head of Q&C
BS ISO 15727 test method: Measuring the output of a UV-C lamp
BS ISO 15727 test method: Measuring the output of a UV-C lamp
BS ISO 15727 test method: Measuring the output of a UV-C lamp

BS ISO 15727: Measuring the Output of a UV-C lamp

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…
By: James Tolmie, Laboratory Scientist
testing to BS EN 14255-1 standards
testing to BS EN 14255-1 standards
testing to BS EN 14255-1 standards

BS EN 14255-1: Measuring Exposure to UV Radiation

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…
By: James Tolmie, Laboratory Scientist
Anti-Microbial Coating Testing
Anti-Microbial Coating Testing
Anti-Microbial Coating Testing

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…
By: Riwia Chetian, Laboratory Scientist
UV-C light bulbs
UV-C light bulbs
UV-C light bulbs

BS 8628 – Disinfection Using Ultraviolet Radiation

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…
By: Enrico Allegra, Head of Laboratory

Electrical Safety  

Laboratory Training Course
Laboratory Training Course
Laboratory Training Course

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 course…
By: Toni Carlton, Head of Q&C
Medical device material compatibility
Medical device material compatibility
Medical device material compatibility

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…
By: Tautvydas Karitonas, MD
IEC 60601-1 at Test Labs
IEC 60601-1 at Test Labs
IEC 60601-1 at Test Labs

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…
By: James Tolmie, Laboratory Scientist
You Need Pre-Compliance Evaluation – here’s why Image
You Need Pre-Compliance Evaluation – here’s why Image
You Need Pre-Compliance Evaluation – here’s why Image

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…
By: James Tolmie, Laboratory Scientist
Good Laboratory Practice & Safe Medical Device Reuse Image
Good Laboratory Practice & Safe Medical Device Reuse Image
Good Laboratory Practice & Safe Medical Device Reuse Image

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…
By: Toni Carlton, Head of Q&C