A Review of the Design Process for Implantable Orthopedic Medical Devices

Abstract

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.

Investigation of the mechanical and chemical characteristics of nanotubular and nano-pitted anodic films on grade 2 titanium dental implant materials

“…The validation of critical processes in the production line is a general requirement for the European and American implant manufacturers and the enforcement of this requirement has become more imperative, recently [28]. However, our findings suggest that the reproducibility and the mechanical integrity of the nanotubular anodic films on 3-dimensional implant geometries is low, if the conventional anodizing parameters are applied, e.g.…”

Lumbar model generator: a tool for the automated generation of a parametric scalable model of the lumbar spine

“…The frequency distribution of the quality criteria of the L1 vertebrae was then compared either with the distribution of the other vertebrae (L2-L5) or the distribution of the models based on different body dimensions, through a quantile-quantile plot (QQ-plot). The IVD mesh was evaluated through a sensitivity study on varying the parameters which influence the mesh size pp (64, 72, 80, 88, 96), nl (8,9,10,11,12) and nz (6, 8, 10, 12, 14), described above. The influence of the VP has not been reported in this study because it is not a parameter relevant to the structural properties of the IVD.…”

Comparison of Student and Faculty Perceptions of Team Performance in Capstone Design Projects as Evaluated by Graduate Attribute-Linked Rubrics

“…Design dossiers and technical design files are universally used in engineering practice [1,2], yet the most common evaluation mechanism used in capstone design courses is the formal engineering report. Students often defer the writing of such reports until the deadline, which can introduce a significant lag between when the original activities occurred and when the writeup takes place.…”