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Team:Dundee/Implementation/methodology
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| - | After obtaining a clear direction for our device from possible future users we spoke to members of industry. In particular we contacted a local company that developed medical equipment; the Institute of Medical Science and Technology. From this we found that the main body for devising procedures by which medical devices should be built is the International Organisation of Standards (ISO). As we live in a global community where such standards are important to ensure that “products and services are safe, reliable and of good quality”<sup>1</sup> there are strict procedures that must be adhered to. During the development of the L.A.S.S.O. we attempted to apply as many of the points given in the quality management standards <a href="http://en.wikipedia.org/wiki/ISO_9000# | + | After obtaining a clear direction for our device from possible future users we spoke to members of industry. In particular we contacted a local company that developed medical equipment; the Institute of Medical Science and Technology. From this we found that the main body for devising procedures by which medical devices should be built is the International Organisation of Standards (ISO). As we live in a global community where such standards are important to ensure that “products and services are safe, reliable and of good quality”<sup>1</sup> there are strict procedures that must be adhered to. During the development of the L.A.S.S.O. we attempted to apply as many of the points given in the quality management standards <a href="http://en.wikipedia.org/wiki/ISO_9000#Contents_of_ISO_9001'>9001</a> and <a href='http://www.iso.org/iso/catalogue_detail?csnumber=36786'>13845</a> as we could. Standard 9001 dictates the procedures for general quality management; giving standards a company should follow when developing a product. Standard 13485 expands on 9001 to specify how a medical device should be developed. |
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Revision as of 18:53, 11 October 2014
Methodology
Work like a professional
User based approach
The L.A.S.S.O. is more than just the development of an idea; we wanted to see whether this device could be realistically implemented in society. To create a product that had a future in the real world we decided it would be best to talk to people we envisioned using it. People who understand the daily struggles and realities of treating cystic fibrosis. So we took a customer based approach by meeting with patients and medical staff to hear their view on how the L.A.S.S.O. should be designed to best meet their needs.
ISO Standards
After obtaining a clear direction for our device from possible future users we spoke to members of industry. In particular we contacted a local company that developed medical equipment; the Institute of Medical Science and Technology. From this we found that the main body for devising procedures by which medical devices should be built is the International Organisation of Standards (ISO). As we live in a global community where such standards are important to ensure that “products and services are safe, reliable and of good quality”1 there are strict procedures that must be adhered to. During the development of the L.A.S.S.O. we attempted to apply as many of the points given in the quality management standards
References
