Biocompatibility failures are usually the result of avoidable gaps in classification, risk assessment, and test strategy. By aligning biological evaluation with ISO 10993 and ISO 14971 from the outset, manufacturers can significantly reduce retesting, delays, and regulatory friction.

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…

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…

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…

Biocompatibility is essential to medical device safety, compliance, and global market approval. Guided by ISO 10993 and ISO 14971, it ensures devices perform without harming patients while meeting evolving regulatory standards. Regular updates and risk-based strategies are key to maintaining…

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…

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.

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.

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…

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.

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.

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 8628:2022 establishes a standardised method for testing and validating the performance of automated UV surface disinfection systems. It enables consistent, science-based comparison of UV technologies across healthcare, pharmaceutical, and other high-risk environments.

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.