Risk Mangement Medical Devices

Application Risk Management for medical devices

This book provides a reference for people working in the design, development, and manufacturing of medical devices. ​While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes.

To paraphrase a popular saying, usability testing should be done early and often.

This book focuses on the challenges and potentials of open source and collaborative design approaches and strategies in the biomedical field. It provides a comprehensive set of good practices and methods for making these safe, innovative and certifiable biomedical devices reach patients and provide successful solutions to healthcare issues.

Force and Position Control of Mechatronic Systems provides an overview of the general concepts and technologies in the area of force and position control. Novel ideas and innovations related to this area are presented and reported in detail, and examples of applications in medical technology are given.