Medical Device Label Durability Validation

We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.

Regulatory frameworks for medical devices mandate a Unique Device Identifier (UDI) system be put in place to allow for identification and facilitate traceability of devices. To ensure all markings on a medical device or its’ packaging continues to meet labelling regulatory and statutory requirements throughout its lifetime we perform assessments to validate their readability and durability.

Unreadable and misread barcodes can cause a breakdown in the supply chain, delaying deliveries and even put patients at risk meaning that verification should be considered as part of the risk management of a device. This can include ensuring that the etching/marking process successfully produces a compliant barcode or testing the corrosion and/or fading of the markings due to stresses that could occur during its life cycle.

With the changes in technology there are now a range of types of barcodes and different printing/finishing methods that can be selected to add markings containing essential information to devices and their packaging. When selecting the method to be used during production, the manufacturer must ensure there is no negative impact on product safety or interfere with the effectiveness of the device throughout the life cycle of the product. Once this has been selected, the quality and compliance against the requirements must be repeatably produced as well as withstand different stresses the product may be exposed to.

FDA Medical Device requirements: Everything You Need to Know

A comprehensive FDA guide outlining regulatory requirements for US medical devices

A Guide to Good Laboratory Practice (GLP): Everything You Need to Know

GLP is a defined set of principles to be implemented in a QMS by an organisation completing non-clinical studies

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

The purpose of a PMS system is to identify risks, not previously known, and opportunities for improvement in a timely fashion

Explore our medical device testing services

Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

Medical devices bioburden testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

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Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials

Strong foundations are built with robust Quality Management Systems