Meeting European and US requirements for design and development documentation, Part I

Developing design and development procedures and documentation is one of the most important activities in the implementation of a formal design-control programme. Also, companies wishing to comply with the European and the forthcoming United States (US) requirements face a dual challenge. Part I of this series of articles will provide an overview of design control elements and some differences between the European and US requirements. The next two parts will discuss the types of procedures and documentation that are needed to comply with these requirements and a method for organizing documentation to facilitate its use by the company and auditors.