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.

Everybody Farts: Celebrating the Body and Refuting Medical Paternalism in Joyce's Ulysses

James Joyce’s Ulysses celebrates all facets of daily life in its refusal to censor raw human emotions and emissions. He adopts a critically medical perspective to portray this honest, unfiltered narrative. In doing so, he reveals the ineffectiveness of the physician-patient relationship due to doctors’ paternalistic attitudes that hinder nonjudgmental, open listening of this unfiltered narrative. His exploration of the doctor’s moral scrutiny, cultural prejudices, and authoritative estrangement from the patient underscore the importance in remembering that physicians and patients alike are ultimately just fellow human beings. Wryly, he drives this point to literal nausea, as his narrative proudly asserts the revulsive details of public health, digestion, and death. In his gritty ruminations on the human body’s material reality, Joyce mocks the physician’s highbrow paternalism by forcing him to identify with the farting, vomiting, decaying bodies around him. In celebrating the uncensored human narrative, Joyce challenges physician and patient alike to openly listen to the stories of others.

MW, Medical Watches

My project is a business plan about the set up of a company and the development of a new and innovative product aimed for the elders. I decide do this project when I discover that one of the more important needs that have the elders is to remember the medicines that they have to take. I thought that a good way could be through a smart watch. My watch have an only function, is a cheap device, easy to use, easy to understand and easy to set up, because the elders usually do not know to use complex electronics devices. There are other similar smart watches and other devices but do not have the necessary characteristics to be a good reminder for elders. My watch is centred to improve the life of the elders, but my product could also be useful for ill people who have to take many medicines during the day. After realizing this business plan, I have proved that my company is viable in the environment and profitable in the market.