The new CRO intends to to positively impact the timeline of regulatory clearance and increase profitability for medical device firms, in order to launch their new research discoveries and product concepts into the market.
It will provide specialized regulatory and clinical expertise in medical devices and cost-efficient services from start to finish to the small and large companies.
The firm’s medical device experts serve as a liaison for device manufacturers from inception to commercialization, offering firms with subject matter expertise and regulatory experiences to launch new products into the markets.
CSSi will involve in all phases of medical device development ranging from design engineering and testing to clinical studies and reimbursement.
The services offered include regulatory filings to US and foreign notified bodies, clinical study planning, monitoring, and reporting, FDA and EMA agent for foreign registration, medical device testing and design history files.
Others services provided include quality management systems (21 CFR 820 and ISO 13485), health authority interactions, and regulatory and scientific communication.
CSSi LifeSciences president and partner Jim Sergi said: “We take pride in being an industry leader, as well as creating a new breed of CRO, one that focuses specifically on the medical device industry.
“We believe taking this approach in today’s new world of healthcare is intelligent, critically honest, and backed by a history of verifiable results, including over two hundred and fifty successful 510(k) applications.”
