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…

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,…

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…

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.

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…

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…

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…

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

Low temperature hydrogen peroxide sterilisation (VHP) provides an effective, low-residue alternative for heat and moisture-sensitive medical devices. Guided by ISO 22441:2022, it requires rigorous validation and material compatibility testing to ensure consistent sterility and device integrity. When properly validated, VHP…

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

Quality testing in medical devices ensures safety, compliance, and performance from concept to market. By verifying material integrity, chemical safety, and mechanical strength, it prevents failures and builds confidence in device reliability. It’s a strategic investment that protects patients, reputation,…

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.

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

Manual disinfection is essential for heat-sensitive reusable medical devices that can’t undergo sterilisation. Breaking down when, why, and how manual disinfection is used, including regulatory standards, Spalding classification, and critical process controls that medtech leaders must know to stay compliant…

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.