This article explores cytotoxicity testing, a critical step in assessing the biocompatibility of medical devices. It explains how cytotoxicity studies are conducted using in vitro methods to evaluate whether materials used in a device cause cell damage or death.

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…

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…

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,…

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…

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

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 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…

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…

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

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…

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

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.

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…

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.

This course is specifically designed for medical device manufacturers seeking to enhance their understanding of laboratory processes and regulatory requirements for medical devices.