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…

The latest edition of ISO 10993-1:2025 introduces important updates to the biological evaluation of medical devices, strengthening integration with ISO 14971 and introducing revised contact categorisation and biological effects.

Particulate contamination presents a serious but often overlooked risk to medical device safety, particularly when particles enter the bloodstream. Understanding where particulates originate, how they are extracted and analysed, and which standards define acceptable limits is essential for protecting patients,…

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…

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…

Instructions for Use are essential documents that guide users on the correct, safe, and effective handling of medical devices. They outline validated cleaning, disinfection, and sterilisation procedures to minimise infection risks and ensure regulatory compliance.

Medical device sterilisation ensures patient safety by eliminating microorganisms. Manufacturers must rigorously validate sterilisation methods based on device type. Validation follows standards like ISO 17665 and proves consistent Sterility Assurance Levels (SAL). Clear Instructions for Use (IFU) and proper validation…

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…

Integrated electronic traceability is transforming medical device reprocessing by unifying fragmented systems into a single, data-driven ecosystem. This shift enables real-time visibility, improved patient safety, operational efficiency, and measurable sustainability across healthcare workflows.

Incompatibility between disinfectants and device materials results in equipment damage and higher HAI rates. Understanding and addressing root causes is essential.

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

Chemical agents used during medical device cleaning, disinfection, and sterilisation can degrade metals and polymers, leading to corrosion, embrittlement, discoloration, and additive leaching. These changes can compromise performance, safety, and regulatory compliance. Understanding material compatibility, controlling processing parameters, and validating…

Visual degradation after cleaning, disinfection, or sterilisation is often dismissed as cosmetic, but it can indicate deeper mechanical or chemical damage. Identifying and managing surface changes early is critical to maintaining medical device safety, performance, and compliance.

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.

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.