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…

ISO 10993 and ISO 18562 are complementary biocompatibility standards used to evaluate medical device safety. ISO 10993 focuses on biological risks from materials in contact with tissue, while ISO 18562 addresses inhalation risks from devices delivering breathing gases. Knowing which…

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…

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…

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…

The importance of validating cleaning, disinfection, and sterilisation instructions for reusable medical devices and highlights of how ISO 17664 compliance protects patients and supports manufacturers in meeting regulatory requirements.

Service life validation demonstrates that a medical device continues to perform safely and effectively throughout its intended lifespan. It verifies durability under expected use, maintenance, and reprocessing conditions, supporting ISO 14971 compliance and risk management. By replicating real-world stressors, customised…

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…

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.

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

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

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

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.

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

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.

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

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.