CSSi LifeSciences provides a fully integrated one-stop shop for medical device technologies from inception and “back of a napkin” ideation to commercialization.
The pathway from design to commercialization for a new medical device can be ambiguous and complex. The US FDA CDRH and other competent health authority regulations and requirements change frequently and vary by level of risk, specific product claims, and intended use.
We have experience successfully navigating complex regulations in over 100 countries with over 300 combined years of experience and knowledge. More importantly, our team has achieved a 100% success rate with over 250 products!