How can IVD and medical device manufacturers ensure their products comply with changing user requirements?
IVD and medical device development are dynamic and complex, accompanied by increasing pressure to develop new tests and protocols quickly under changing user requirements. Because there are often no specific standardized processes available, creating innovative tests and methodologies necessitates designing testing strategies with tailored approaches.
Developing a characterization and verification assay for products like COVID-19 polymerase chain reaction (PCR) tests, determining a product's antimicrobial efficacy, or evaluating potential contamination of a medical device requires extensive knowledge of a wide range of microbiological, molecular, and chemical technologies, as well as in-depth experience with the changing public health and regulatory landscape.
Exponent's Microbiology & Molecular Biology Laboratory team specializes in quickly developing customized testing while adhering to industry quality standards. We have the in-house expertise to perform protocol development, quality control checks, and comprehensive microbiological testing, including antibiotic susceptibility testing, antimicrobial efficacy testing, disinfection and cleaning assessments, and contamination sampling and analysis.
Working with bacteria (e.g., Escherichia coli, Staphylococcus aureus, Burkholderia cepacia), bacteriophages (e.g., MS2), inactivated viruses (e.g., inactivated SARS-CoV-2), and other biosafety level 2 (BSL-2) pathogens, we can design model systems for extensive testing. Our customized approach also entails risk mitigation and failure analysis, as well as assay development and verification.
Exponent's microbiology and molecular biology experts can help assess and address potential medical device and invitro diagnostic risks for a range of applications at any point along the total product lifecycle.
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