CSSi LifeSciences, a trusted partner from discovery to commercialization for drugs and medical devices, announced the establishment and launch of its fully integrated Medical Device CRO. CSSi LifeSciences Medical Device CRO aims to positively impact the timeline of regulatory clearance and increase profitability for medical device companies, in order to successfully launch its innovative research discoveries and product concepts into the market.
CSSi LifeSciences supports small and large companies in avoiding the "large CRO shuffle" by providing highly specialized regulatory and clinical expertise in medical devices, while also offering unparalleled and cost-efficient services from start to finish. The company's goal is to accelerate product development by providing insight-driven guidance that saves time and cost.
"The pathway to commercialization for a new medical device can be ambiguous and complex due to ever-changing regulations and requirements. To help companies overcome this barrier, we developed our unique Medical Device CRO," said Jim Sergi, president and partner, CSSi LifeSciences. "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."
In an effort to meet the growing demands of the medical device market, CSSi LifeSciences's team of medical device experts serve as a liaison for device manufacturers from inception to commercialization, leveraging deep subject matter expertise and regulatory experiences to effectively move new products to market with speed, accuracy, and the quality necessary to ensure safety, compliance, and health authority approval.
"Collectively, our medical device team has over 100 years of development and commercialization experience, coupled with global regulatory knowledge that goes beyond published guidance documents and initiatives," said Sergi. "Our team possesses the necessary skills and resources to make our clients' medical device efforts an end-user success."
CSSi LifeSciences supports all phases of medical device development, from design engineering and testing to clinical studies and reimbursement. The company offers a broad suite of comprehensive and scalable services, including regulatory filings to U.S. and foreign Notified Bodies; clinical study planning, monitoring, and reporting; FDA and EMA Agent for Foreign Registration; medical device testing and Design History Files; Quality Management Systems (21 CFR 820 and ISO 13485); health authority interactions; and regulatory and scientific communication.