991 resultados para Medical Advisory Boards.
Resumo:
The STREAM Initiative set logframe indicators, at their Technical Advisory Committee meetings and this is a progress report based on given indicators. It further includes two articles: The Kandhkelgaon story: A bold bid by women in Kandhkelgaon Village, Saintala Block, Bolangir District, to break out of their poverty trap, by Graham Haylor, S.D. Tripathi, B.K. Satpathy and Dipti Behera. Networking for rural development: a closer look at the evolution of communications in the STREAM Initiative, by Graham Haylor, Kath Copley and William Savage. (PDF contains 27 Pages)
Resumo:
(pdf contains 23 pages)
Resumo:
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.