In order to market a medical device in the United States or the European Union (as well as other regions of the world), a manufacturer …
Medical Device Design Controls
Developing a new medical device from concept to market can be a complex process. Design controls are an interrelated set of practices and procedures that …
Combination Product Compliance
In the United States, a combination product is any product composed of a combination of a drug and a device, a drug and a biological …
Medical Device Design
Developing a new medical device, from concept to market, can be a complex process. Design controls are an interrelated set of practices and procedures that …