Chemical characterisation is a crucial process in assessing the safety and biocompatibility of medical devices by identifying and quantifying the chemicals that make up their materials. Guided by ISO 10993-18, it ensures manufacturers understand potential chemical risks, enabling informed material…

Cytotoxicity testing is a critical step in ISO 10993 biocompatibility assessments, helping medtech leaders ensure device safety, manage regulatory risk, and select the most suitable method - qualitative, quantitative, or agar overlay - based on device type, patient contact, and…

A personal reflection on how biological evaluation shaped the author’s life, from life-saving but imperfect neonatal blood bags to growth-hormone therapies and early medical devices, and how these experiences now inform a human-centred approach to designing safer, smarter medical technologies…

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.

Over-extraction in medical device testing often produces results that don’t reflect real clinical use, leading to misleading toxicological profiles, credibility risks, and regulatory delays. By applying clinically relevant extraction methods, reducing measurement uncertainty, and aligning with regulatory expectations, medtech companies…

Worst-case justification allows medical device manufacturers to validate reprocessing using the most challenging device in a product family, saving time, cost, and resources. Test Labs applies a structured, standards-based approach aligned with ISO and AAMI guidance to identify, assess, and…

Real-world gaps in IFUs and reprocessing workflows demand strategic action from medtech leaders to protect patients and support SPD teams.

Residual hydrogen peroxide can pose hidden risks in sterilised medical devices, impacting both patient safety and regulatory compliance. ISO 22441 and ISO 10993 standards provide frameworks for assessing toxicological risk, guiding manufacturers through chemical characterisation, extraction studies and Margin of…

Medical device lifecycle testing is essential for regulatory approval, especially for reusable instruments subject to repeated sterilisation. Benchtop autoclaves, when combined with sensors and dataloggers, can speed up testing cycles and improve data accuracy, helping smaller labs deliver rapid, reliable…

In order to gauge the most accurate representation of the cleaning procedure, the validation experiments require the test device to be in a similar form to an actual ‘in-use’ device, to stimulate the effectiveness of the cleaning process in a…

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures

Material compatibility testing ensures medical devices maintain safety and performance throughout cleaning, sterilisation, and use. It helps manufacturers choose appropriate materials and reprocessing methods.

HALT, or Highly Accelerated Life Testing was a term coined by Gregg K. Hobbs in 1988, describing an aggressive methodology of stress testing.

Shelf-life stability and expiration dates are determined through aging studies, in which the disinfectants are stored for a specific period under specific conditions and the physical and chemical properties of the disinfectant tested.

The ISO 22196:2011 standard provides the procedure to quantitatively evaluate the anti-microbial activity of a plastic or non-porous material.

This course is specifically designed for medical device manufacturers seeking to enhance their understanding of laboratory processes and regulatory requirements for medical devices.

While Good Laboratory Practice principles were originally intended for non-clinical studies in the chemical and pharmaceutical sectors, their scope has expanded to other industries, such as medical devices.

Medical device and IVD safety relies on IEC 60601-1 and IEC 61010-1 standards. Understanding MOPP, MOOP and clearances is critical for risk management and regulatory compliance. These standards guide manufacturers in delivering safe, compliant and reliable products.

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures