Download Class 1 Devices: Case Studies in Medical Devices Design by Peter J Ogrodnik PDF

By Peter J Ogrodnik

The Case stories in scientific units Design sequence comprises functional, utilized case reviews in relation to scientific equipment layout in undefined. those titles supplement Ogrodnik’s scientific machine layout and should help engineers with utilising the speculation in perform. The case reviews provided at once relate to category I, classification IIa, category IIb and sophistication III clinical units. Designers and firms who desire to expand their wisdom in a particular self-discipline on the topic of their respective type of operation will locate all or any of those titles an exceptional addition to their library.

Class 1 Devices is a significant other textual content to Medical units layout: Innovation from suggestion to Market. The goal of this publication, and its sister books within the sequence, is to aid the options offered in clinical units layout via case reports. within the context of this publication the case experiences ponder classification I (EU) and 510(k) exempt (FDA) . This publication covers classifications, the conceptual and embodiment part, plus layout from inspiration to PDS.

  • These titles will help an individual who's operating within the scientific units or who's learning biomedical topic parts to layout a profitable clinical equipment and steer clear of repeating earlier mistakes.
  • Written through an skilled scientific machine engineer and entrepreneur, with genuine global adventure of constructing and commercializing clinical products.
  • Joins up conception and perform in an available style.

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Extra info for Class 1 Devices: Case Studies in Medical Devices Design

Example text

2*body weight across the knee. 2 kN. Literature Torsional load The maximum torsional load the device should transfer is 1 Nm. Technical review Pressure Knee brace Now, let us look at the individual case studies in more detail, as it is this section that is likely to provide the difference between them. Take for example the loading on the elasticated hose in comparison to the loading on the metal knee brace. The elasticated hose will only supply pressure; it has no ability to provide any structural support at all.

What will be the issues? That is what FMEA is all about; it helps us to decide what failures we need to ‘design out’. As I said earlier, not doing this is an inexcusable error when designing any medical device of any classification. I hope that this case study has demonstrated the power of FMEA. If we do our design blind, then we will always have problems. However, this case study has demonstrated that the IFU9 has led to design elements related to calculations, testing and contents of any instructions for use.

4. Detailed drawings of all components and assemblies. 5. Calculations/simulations demonstrating performance. 6. A resumé/summary of application of quality in design. 7. Results of any physical tests. 8. List of suppliers of components/materials (with approximate – but not too approximate – costs). 9. Sample labelling. 10. Sample IFU (single language, no point going multi-lingual yet). 11. Sample packaging. 12. A physical/virtual representation of the device as appropriate. 5 Embodiment Phase 51 could be a pdf file or a virtual document).

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