Regulatory Affairs

In today’s market, medical device companies pursuing commercialization need a global regulatory strategy. We can assist your company with defining and implementing the regulatory strategy at every stage of the product development process- from idea to marketing.

CSC provides regulatory support in multiple ways:

• Developing regulatory strategy and submissions

• Identification of applicable regulatory requirements, market and customer drivers

• Device classification and predicate device searches

• Pre-market submissions / CE submissions

• Pre-IDE meeting preparation, including development of pre-meeting packet

• Agency/ NB/ CA interaction

• Conducting due diligence for investment on medical device startup

• Ad hoc hourly consultation and advice