FULLY INTEGRATED MEDICAL DEVICE CRO
Taking designs, prototypes and products through regulatory submissions into commercialization.
The pathway from design to commercialization for a new medical device can be ambiguous and complex. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use.
CSSi LifeSciences™ aids small to large companies avoid cost-prohibitive, large CRO’s by offering efficient, fully-integrated expertise and services from start to finish.
ROAD MAP TO SUCCESS FOR MEDICAL DEVICES
CSSi LifeSciences™ Medical Device CRO has experience navigating regulations in
over 100 countries. Often companies struggle with the pathways for a medical device
from design to commercialization because of the ambiguity and complexity of the
process. Regulations and requirements change frequently and vary by notifying bodies,
country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our
diverse team has many years of medical device commercialization experience, with
knowledge that goes beyond published guidance, documents and initiatives. CSSi
LifeScience™ Medical Device CRO aims to impact the timeline of regulatory
clearance and increase profitability.
CSSi LifeSciences™ Medical Device CRO designs and implements a competitive, cost-effective regulatory strategy, including preparation and submission of a marketing application. Our experts serve as your liaison from inception to commercialization, leveraging expertise and past experience to effectively aid in negotiation with the US FDA, EU, and international regulatory agencies.
Our medical device team possess the skills and resources to transform your product concept, at any stage, to a commercially viable and profitable medical device.