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,…

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…

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…

A practical guide to building Biological Evaluation Reports (BERs) that meet today's Notified Body expectations through chemistry-led evidence, robust toxicological assessment and integrated risk management.

Reusable medical devices face increased regulatory scrutiny under MDR and FDA expectations, with reprocessing now requiring clear, defensible evidence. Common failures occur in cleaning validation, disinfection efficacy, sterilisation justification, service life testing, and post-reprocessing biocompatibility. Strong validation programmes start with…

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…

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…

Retesting is costly and avoidable. This article breaks down the 10 most common IFU mistakes that trigger rework, and how to fix them early.

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.

Mechanical degradation caused by repeated medical device reprocessing can lead to fatigue, cracking, surface wear, and loss of function. Understanding these risks, and validating durability through service-life testing is essential for safe reuse and regulatory compliance.

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,…

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…

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…

BS EN 17272 standardises how airborne room disinfection systems are tested, enabling measurable, repeatable validation of whole-room microbial efficacy.

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.

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.