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
Outlook
Microsoft Office 365
Google Cloud Hosting
Mobile Friendly
Remote
Keywords
medical equipment manufacturing
eu regulations
medical device development
ivd regulatory support
regulatory strategy
market entry support
de novo pathway
market access support
regulatory risk assessment
regulatory agency liaison
regulatory submissions
global regulatory landscape
regulatory consulting
quality assurance
clinical affairs
regulatory support for high-risk devices
510(k) clearance
product development
regulatory pathway planning
clinical and regulatory consulting
other scientific and technical consulting services
product approvals
clia and ny clep lab compliance
ldt to fda gmp transition
gmp/qsr compliance
healthcare equipment & supplies manufacturing
iso standards
compliance strategy
global market approval
design transfer to manufacturing
Company Information
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Employees 1
Location
9900 Broadway St, Pearland, Texas, United States, 77584-8091
