New and novel products are a necessity in the medical device market. Industry investment in innovation delivers life enhancing healthcare devices, diagnostics, and digital solutions. Hand-in-hand with product innovation is its innovative test methods, to support efficacy and safety claims of novel products. The use of appropriate test methods support rapid product development and regulatory approval. Conversely, inappropriate test methods can slow product development and hinder/prolong regulatory approval. When innovative devices are being developed, standard test methods may not be fit for purpose. Customized test methods are developed to meet the product needs, examples include the assessment of viral barrier properties, an assessment of anti-attachment properties of a product and demonstration of microbial ingress risk of novel medical devices. A customized test method may include testing of an atypical organism (such as fungi, anaerobes, or antibiotic resistant organisms), analysis of a device using a ‘real-world’ model (ex vivo or in vitro), or the use of simulated fluids such as urine, wound exudate or saliva. There is a trend for regulatory bodies to demand even more clinically relevant in vitro data, where possible within a GLP complaint data file.
What is GLP?
GLP is a managerial quality system, that applies to non-clinical health and environmental safety studies, and ensures a reproducibility, consistency, and integrity of results through ensuring the environment and processes of the study are planned, monitored, recorded, reported, and retained. GLP studies, in the medical device scope, apply the principles to non-clinical safety testing of device, and are often a requirement requested by a global regulatory body in order to get a breakthrough device to market. The data provided from GLP test studies, supports a product’s safety claims, and provides an analysis of the level of risk of the device. Ensuring that the Sponsor initiates a GLP study (if required) at a commercially focused, independent CRO is critical to support these breakthrough devices.
GLP complaint testing alongside innovation
At Perfectus Biomed Group, now part of NAMSA, we bring an expertise in customizable microbiology, viral and cell-based test methods, providing manufacturers with a different perspective when looking to bring innovation to market. Customised studies can be fully validated ahead of being run to GLP, providing the highest level of data credibility for a highly customised method. Studies are designed and performed independently from the Sponsor, by a dedicated team that produce unbiased results. The GLP quality system uses a set of OECD principles to assure the quality and integrity of laboratory studies and the integrity of data produced by harmonizing testing procedures.
Our quality and lab teams are committed to providing the highest level of quality assurance. We hold GLP compliance and are regularly inspected by MHRA which includes a review of the GLP quality systems, inspection of facilities and audit of completed and on-going studies.
To find out more about innovative, customizable test methods, or GLP complaint studies, contact us today at email@example.com