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…

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…

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…

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…

Worst-case justification allows medical device manufacturers to validate reprocessing using the most challenging device in a product family, saving time, cost, and resources. Test Labs applies a structured, standards-based approach aligned with ISO and AAMI guidance to identify, assess, and…

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…

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

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

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.

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,…

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.