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 10993-12:2021 is a critical but often overlooked standard that defines how medical devices must be prepared and extracted before biocompatibility testing. Proper sample preparation ensures accurate, clinically relevant results and prevents regulatory setbacks caused by false positives, missed risks,…

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…

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.

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 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.

Post-cleaning, any residual ATP is collected from the sample and measured using the ATP bioluminescence monitor

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…

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.

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…

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.

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

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.

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,…

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.

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.