About
At Ascent Biomedical, we provide full lifecycle support for seamless market access and commercialization: Design & Development: Risk management, verification/validation, FDA & OUS submissions, design transfer, and regulatory/quality support. Regulatory & QMS Compliance: FDA GMP/QSR (21 CFR 820), ISO 13485, FDA Class III, Class II, IVD Devices, and ISO 15189, CLIA/NY CLEP. Market Success: Expert guidance ensuring compliance, quality, and global commercialization.
Technologies
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Keywords
medical equipment manufacturingeu regulationsmedical device developmentivd regulatory supportregulatory strategymarket entry supportde novo pathwaymarket access supportregulatory risk assessmentregulatory agency liaisonregulatory submissionsglobal regulatory landscaperegulatory consultingquality assuranceclinical affairsregulatory support for high-risk devices510(k) clearanceproduct developmentregulatory pathway planningclinical and regulatory consultingother scientific and technical consulting servicesproduct approvalsclia and ny clep lab complianceldt to fda gmp transitiongmp/qsr compliancehealthcare equipment & supplies manufacturingiso standardscompliance strategyglobal market approvaldesign transfer to manufacturing
Company Information
- Employees1
Location
9900 Broadway St, Pearland, Texas, United States, 77584-8091
