Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.

Zooplankton: its biochemistry and significance in aquaculture

Zooplankton are an important food source for many species of fish. They can provide an inexpensive alternative to other commercial feeds. Zooplankton have several advantages, among them a faster growth and greater feed efficiency for some species. The flavor and texture of fish are also improved with zooplankton as feed. Further research is needed on the chemical composition of zooplankton, the development of zooplankton-based dry diets and the effects of the replacement of fish meal with zooplankton meal for commercial aquaculture species.