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.

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…

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…

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…

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…

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.

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.

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.

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

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.