FDAnews Device Daily Bulletin

CSSi LifeSciences Launches Medical Device CRO

Nov. 3, 2016

CSSi LifeSciences has launched its fully integrated Medical Device CRO, which is designed to accelerate regulatory clearance for medical device companies.

The company offers specialized regulatory and clinical services to support the entire product lifecycle, including: regulatory filings to U.S. and foreign authorities; clinical study planning, monitoring, and reporting; FDA and EMA agent for foreign registration; medical device testing and design history files; quality management systems; health authority interactions; and regulatory and scientific communication. — Cynthia Jessup

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