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One Product, Two Systems: Why Regulatory Divergence is Slowing MedTech Innovation

Introduction For many MedTech startups, expanding into both the US and EU feels like a natural goal. On paper, the product is ready. The team has done their clinical homework. Maybe the FDA 510(k) is already in progress. Surely the EU… Read More

News

Tautvydas Karitonas Test Labs Q2 Changed Gears. We Supercharged It with Focus
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

Popular Articles

Features Tell, Benefits Sell, Value Transforms – All Within Compliance Med-Tech Innovation Expo – From A Delegate Perspective Test Labs’ Pakistan Trip: A Closer Look IEC 60601-1: Everything You Need to Know

Insights  

Our First Time at RAPS Image
Our First Time at RAPS Image
Our First Time at RAPS Image

Our First Time at RAPS

Test Labs attended the RAPS EU Convergence for the first time as part of the MDR Competence Group, marking several firsts, including visiting Brussels and taking the Eurostar. The event delivered strong value through expert-led sessions, networking opportunities, and outstanding catering.
By: Marianne Browning, Business Development
Small Changes, Big Impact on Customer Experience Image
Small Changes, Big Impact on Customer Experience Image
Small Changes, Big Impact on Customer Experience Image

Small Changes, Big Impact on Customer Experience

Invest in better Customer Experience Time is the most valuable resource in business, especially in the medical device industry, where timing can make or break success. Every minute counts. Having immediate access to the right information is critical when bringing…
By: Tautvydas Karitonas, MD
UKCA mark
UKCA mark
UKCA mark

How to obtain UKCA mark for Medical Devices

Regulating Medical Device in the UK – UKCA guidance Following the UK’s exit from the European Union (EU), medical device manufacturers wanting to obtain UKCA mark and place their product on the market in Great Britain (GB) must now comply…
By: Toni Carlton, Head of Q&C
Post-Market Surveillance (PMS): Everything You Need to Know Image
Post-Market Surveillance (PMS): Everything You Need to Know Image
Post-Market Surveillance (PMS): Everything You Need to Know Image

Post-Market Surveillance (PMS): Everything You Need to Know

What is post-market surveillance? According to the EU 2017/745 Medical Device Regulation (MDR), post-market surveillance (PMS) is defined as all activities manufacturers must carry out to keep up to date a procedure for proactively collecting and reviewing evidence gained from…
By: Toni Carlton, Head of Q&C
Medical Device Expert Spotlight – Riwia Chetian Image
Medical Device Expert Spotlight – Riwia Chetian Image
Medical Device Expert Spotlight – Riwia Chetian Image

Medical Device Expert Spotlight – Riwia Chetian

Medical Device Expert Spotlight At Test Labs, our greatest asset is our team – their expertise, dedication, and passion drive everything we do. In this Expert Spotlight, we are excited to introduce Riwia, our talented Microbiologist, and explore the…
By: Test Labs,
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
Regulation of High-Risk and Maximum-Risk Medical Devices in Brazil: Advances and Challenges Image
Regulation of High-Risk and Maximum-Risk Medical Devices in Brazil: Advances and Challenges Image
Regulation of High-Risk and Maximum-Risk Medical Devices in Brazil: Advances and Challenges Image

Regulation of High-Risk and Maximum-Risk Medical Devices in Brazil: Advances and Challenges

Introduction The regulation of medical devices in…
By: Camila Pires Mastrorosa, Regulatory Affairs for Medical Devices

Instructions For Use  

Medical Device Barcode Verification
Medical Device Barcode Verification
Medical Device Barcode Verification

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…
By: Riwia Chetian, Laboratory Scientist
Total Viable Count: Everything You Need to Know Image
Total Viable Count: Everything You Need to Know Image
Total Viable Count: Everything You Need to Know Image

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…
By: Riwia Chetian, 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
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
Ignoring Sterile Processing in Medtech Training Creates Risk. Here’s Why Inclusion, Collaboration and Clear Communication Make All the Difference Image
Ignoring Sterile Processing in Medtech Training Creates Risk. Here’s Why Inclusion, Collaboration and Clear Communication Make All the Difference Image
Ignoring Sterile Processing in Medtech Training Creates Risk. Here’s Why Inclusion, Collaboration and Clear Communication Make All the Difference Image

Ignoring Sterile Processing in Medtech Training Creates Risk. Here’s Why Inclusion, Collaboration and Clear Communication Make All the Difference

Real-World Challenges in Reprocessing Imagine a crucial step in patient safety being overlooked. That’s often the reality for sterile processing departments (SPD). Without proper inclusion and clear communication, the risk of improper reprocessing skyrockets, putting patients in harm’s way…
By: Sasha Nunez, Sterile Processing Technician | Healthcare Visual Content Creator

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
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
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
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
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

Compatibility  

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
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
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
Chemical Disinfectants Storage and Shelf-life Stability Image
Chemical Disinfectants Storage and Shelf-life Stability Image
Chemical Disinfectants Storage and Shelf-life Stability Image

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…
By: Syeda Begum, 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  

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
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
Hydrogen Peroxide Vapour Decontamination Cycle Parameters Image
Hydrogen Peroxide Vapour Decontamination Cycle Parameters Image
Hydrogen Peroxide Vapour Decontamination Cycle Parameters Image

Hydrogen Peroxide Vapour Decontamination Cycle Parameters

Hydrogen peroxide vapour (HPV), as we know it, has been employed for decades in bio-decontamination technology systems to decontaminate hospitals and decrease rates of hospital-acquired infections. HPV was shown to kill microorganisms by interacting with their lipid membranes and disturbing…
By: Tautvydas Karitonas, MD
Bioburden Testing: Everything You Need to Know Image
Bioburden Testing: Everything You Need to Know Image
Bioburden Testing: Everything You Need to Know Image

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…
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
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
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
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
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