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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. Read More

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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

Press coverage of Test Labs launch General Surgical Instruments: Everything you need to know Q1 Moves Fast – But We Moved Faster Test Labs Supports COP26

Insights  

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
Environmental Sampling
Environmental Sampling
Environmental Sampling

Environmental Sampling Services: Why Every Health Trust Needs Them

Why does our Health Trust need Environmental Sampling Services? Monitoring your healthcare environment through environmental sampling is as essential to infection prevention and control (IPC) as maintaining rigorous disinfection and cleaning procedures. There are two ways in which environmental…
By: Enrico Allegra, Head of Laboratory
Unlocking value and confidence with ISO/IEC 17025 accreditation for testing laboratories Image
Unlocking value and confidence with ISO/IEC 17025 accreditation for testing laboratories Image
Unlocking value and confidence with ISO/IEC 17025 accreditation for testing laboratories Image

Unlocking value and confidence with ISO/IEC 17025 accreditation for testing laboratories

Unlocking value and confidence with ISO/IEC 17025 accreditation for testing laboratories For testing laboratories, whether already accredited or considering accreditation, ISO/IEC 17025 remains the global standard for demonstrating technical competence and reliability in testing and calibration services. As…
By: Laura Turner, UKAS
Testing Laboratory Net Promoter Score Image
Testing Laboratory Net Promoter Score Image
Testing Laboratory Net Promoter Score Image

Testing Laboratory Net Promoter Score

What is Net Promoter Score (NPS) and why use it? A Net Promotor Score (NPS) is a common metric used by customer service teams across multiple industries by looking at how likely our customers are to recommend our businesses. NPS…
By: Holly Scott, Account Manager
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
Challenges Faced by Medical Device Testing Laboratories Image
Challenges Faced by Medical Device Testing Laboratories Image
Challenges Faced by Medical Device Testing Laboratories Image

Challenges Faced by Medical Device Testing Laboratories

The medical device industry is complex and diverse, presenting unique challenges not only for manufacturers but also for the testing laboratories that support them. While much discussion focuses on the hurdles manufacturers encounter in bringing their products to market, the…
By: Enrico Allegra, Head of Laboratory
Test Labs 2024 USA Marathon Image
Test Labs 2024 USA Marathon Image
Test Labs 2024 USA Marathon Image

Test Labs 2024 USA Marathon

Long Story Short My recent journey across the United States, which I dubbed the “2024 USA Marathon,” offered a rare and direct glimpse into the world of the U.S. medical device industry. With stops in key cities like Boston, Philadelphia,…
By: Tautvydas Karitonas, MD

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
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
Student Live Brief – Improving Disinfection Protocols for Medical Devices Image
Student Live Brief – Improving Disinfection Protocols for Medical Devices Image
Student Live Brief – Improving Disinfection Protocols for Medical Devices Image

Student Live Brief – Improving Disinfection Protocols for Medical Devices

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.
By: Tautvydas Karitonas, MD
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
Dental instruments validation: Everything you need to know Image
Dental instruments validation: Everything you need to know Image
Dental instruments validation: Everything you need to know Image

Dental instruments validation: Everything you need to know

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…
By: Toni Carlton, Head of Q&C

Biocompatibility  

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
Medical Device Biocompatibility Testing: Everything You Need to Know Image
Medical Device Biocompatibility Testing: Everything You Need to Know Image
Medical Device Biocompatibility Testing: Everything You Need to Know Image

Medical Device Biocompatibility Testing: Everything You Need to Know

What is biocompatibility testing, and why should I conduct these tests on my medical device? Biocompatibility testing refers to a set of standards (ISO-10993) that defines the potential biological risks of a device upon encountering the human body, specifically evaluating…
By: Riwia Chetian, Laboratory Scientist
ISO 10993-18: Chemical Characterisation of Medical Device Materials Image
ISO 10993-18: Chemical Characterisation of Medical Device Materials Image
ISO 10993-18: Chemical Characterisation of Medical Device Materials Image

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…
By: Syeda Begum, Laboratory Scientist
ISO 10993-10 Skin Sensitization: Everything You Need to Know Image
ISO 10993-10 Skin Sensitization: Everything You Need to Know Image
ISO 10993-10 Skin Sensitization: Everything You Need to Know Image

ISO 10993-10 Skin Sensitization: Everything You Need to Know

What is ISO 10993-10 Skin Sensitization testing? ISO 10993-10 Skin sensitization testing assesses the possible contact of hazards from chemicals which are released from a medical…
By: Riwia Chetian, Laboratory Scientist
In vitro biocompatibility testing – Skin irritation: Everything You Need to Know Image
In vitro biocompatibility testing – Skin irritation: Everything You Need to Know Image
In vitro biocompatibility testing – Skin irritation: Everything You Need to Know Image

In vitro biocompatibility testing – Skin irritation: Everything You Need to Know

What is in vitro testing and how is it different to in vivo testing? In vitro means ‘in glass’ which essentially refers to testing that occurs in glass vessels (e.g., test tubes), instead of in a human or animal (in…
By: Riwia Chetian, Laboratory Scientist

Compatibility  

Dental Product Material Compatibility Testing – Case study Image
Dental Product Material Compatibility Testing – Case study Image
Dental Product Material Compatibility Testing – Case study Image

Dental Product Material Compatibility Testing – Case study

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: Syeda Begum, Laboratory Scientist
Medical Device Highly Accelerated Life Testing: Everything You Need to Know Image
Medical Device Highly Accelerated Life Testing: Everything You Need to Know Image
Medical Device Highly Accelerated Life Testing: Everything You Need to Know Image

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…
By: James Tolmie, Laboratory Scientist
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
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

Disinfection  

Medical Device Disinfectant
Medical Device Disinfectant
Medical Device Disinfectant

Medical Device Disinfectant – CE Mark verification step-by-step guidance

What classification of medical device is my disinfectant? Annex VIII of the EU 2017/745 Medical Device Regulation (MDR) outlines the classification rules for medical devices. Application of these classification rules should be determined by the intended use of the device.
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
Image showing a mock-up of a control board with settings for different types of cleaning
Image showing a mock-up of a control board with settings for different types of cleaning
Image showing a mock-up of a control board with settings for different types of cleaning

IPC Cleaning Standards in Healthcare

Why are IPC cleaning standard important? Over the last two years, the demand for hospital treatment was outstripping the capacity of UK’s national health service which have led to significant…
By: Tautvydas Karitonas, MD
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
TestLabs scientist working on atp cleaning validation
TestLabs scientist working on atp cleaning validation
TestLabs scientist working on atp cleaning validation

Cleaning validation with ATP : Everything You Need to Know

What does ATP stand for? ‘Mitochondria is the powerhouse of a cell’ is a phrase that should be engrained from many science lessons in school, but what exactly gives the mitochondria its power-like abilities? The answer is an intracellular small…
By: Riwia Chetian, Laboratory Scientist

Electrical Safety  

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
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
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
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