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.

A method for identifying scope and assumptions in developing and selecting methods and tools

This technical report describes a practical method consisting of a checklist and a supporting techniques for those planning or just starting to develop or select design tools and methods. The method helps to summarize and illustrate the envisaged tool or method by identifying its scope and the underlying assumptions. The resulting tool or method description clarifies the problem that is addressed, the approach and the possible implications, and can thus be used by a variety of people involved in assessing a tool or method in an early stage. For the developers themselves the method reveals how realistic the envisaged method or tool is, and whether the scope has to be narrowed.

Soil mix technology for integrated remediation and ground improvement: From laboratory work to field trials

Relatively new in the UK, soil mix technology applied to the in-situ remediation of contaminated land involves the use of mixing tools and additives to construct permeable reactive in-ground barriers and low-permeability containment walls and for hot-spot soil treatment by stabilisation/ solidification. It is a cost effective and versatile approach with numerous environmental advantages. Further commercial advantages can be realised by combining this with ground improvement through the development of a single integrated soil mix technology system which is the core objective of Project SMiRT (Soil Mix Remediation Technology). This is a large UK-based R&D project involving academia-industry collaboration with a number of tasks including equipment development, laboratory treatability studies, field trials, stakeholder consultation and dissemination activities. This paper presents aspects of project SMiRT relating to the laboratory treatability study work leading to the design of the field trials. © 2012 American Society of Civil Engineers.