Medical Devices: Surgical and Image-Guided Technologies by Martin Culjat

By Martin Culjat

Addressing the exploding curiosity in bioengineering for healthcare purposes, this e-book offers readers with particular but easy-to-understand assistance on biomedical gadget engineering. Written by way of widespread physicians and engineers, Medical units: Surgical and Image-Guided Technologies is geared up into stand-alone chapters protecting units and platforms in diagnostic, surgical, and implant procedures.

Assuming in simple terms uncomplicated heritage in math and technology, the authors in actual fact clarify the basics for various platforms in addition to such themes as engineering concerns, healing strategies and purposes, destiny developments, and extra. After describing easy methods to deal with a layout venture for clinical units, the publication examines the following:

  • Instruments for laparoscopic and ophthalmic surgical procedure, plus surgical robotics
  • Catheters in vascular remedy and energy-based hemostatic surgical devices
  • Tissue ablation structures and the various makes use of of lasers in medicine
  • Vascular and cardiovascular units, plus circulatory help devices
  • Ultrasound transducers, X-ray imaging, and neuronavigation

An absolute needs to for biomedical engineers, Medical units: Surgical and Image-Guided Technologies is additionally a useful advisor for college students in all engineering majors and pre-med courses drawn to exploring this attention-grabbing field.

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Extra resources for Medical Devices: Surgical and Image-Guided Technologies

Sample text

Marketing approval for class III high risk (and some class II) devices in the United States is predicated on the manufacturer demonstrating the device to be reasonably safe and effective, which typically requires a prospective, randomized controlled clinical trial. , 2011). , 2004). 3 Standards Medical device standards are applicable to a range of device-related issues, including design, testing, labeling, active implantable devices, sterilization, packaging, risk management, safety, software, biological evaluation, quality management, and various other topics.

The FDA also requires manufacturers of class II and class III medical devices to implement design controls, which are essentially a development and control plan used to manage the development of a new product. The DHF is where these activities are documented. 4 Conceptualizing and Review At this early stage, and depending on the complexity of the proposed device systems involved, the first steps involve successive meetings to deal strictly with rough concepts on paper, just ideas (Fig. 1). This is often a period of brainstorming, for not only the total concept but also components or subsystems that may be involved.

5 Testing and Refinement The individual teams continue working on their assigned areas of the concept. The pertinent principles and mechanisms are usually tested just on their own in order to prove validity, completely separate from any systems functions. This determines whether it can be incorporated into the whole picture. If not, one needs to start over and consider another configuration, because what was envisioned will either be too costly or will not function as intended. Once each of these subparts has been proven to work as predicted, then one has to start looking at the entire picture, taking a systems-based approach.

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