MPLN follows a development process for laboratory developed tests. A phased approach is useful for organizing and assessing the performance of an assay.
This process ensures that a new assay meets regulatory requirements as well as provides a mechanism to fully vet the assay. MPLN has aligned their project management process to follow the FDA 21 CFR part 820.30 design control and the EU Medical device directive 98/79/EC implemented through ISO 13485. The process is documented in a quality development policy that outlines the deliverables for each phase. MPLN's process takes a new assay from discovery to in-house operational level. This development process enables an IVD vendor to integrate MPLN's development data more easily into their own quality management system for future development as an IVD product.
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