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 …
GMP Facility Design
Kymanox has been designing GMP facilities since its inception. We provide upfront facility design layouts and partner with other engineering firms to produce facility permit …
Quality by Design
Quality by Design (QbD) is a structured approach to process development that emphasizes science and risk management principles. Applying QbD allows companies to develop manufacturing …
Item Specifications
A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria …
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 …
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 …
Facility Startup
Greenfield Process Engineering, C&Q and Compliance Support Kymanox consists of a diverse team with a broad range of experience and expertise that allows us to …