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.

Analytical model and experimental validation of friction laws for composites under low loads

In order to account for interfacial friction of composite materials, an analytical model based on contact geometry and local friction is proposed. A contact area includes several types of microcontacts depending on reinforcement materials and their shape. A proportion between these areas is defined by in-plane contact geometry. The model applied to a fibre-reinforced composite results in the dependence of friction on surface fibre fraction and local friction coefficients. To validate this analytical model, an experimental study on carbon fibrereinforced epoxy composites under low normal pressure was performed. The effects of fibre volume fraction and fibre orientation were studied, discussed and compared with analytical model results. © Springer Science+Business Media, LLC 2012.