Cover -- Title Page -- Copyright Page -- Contents -- Foreword -- Chapter 1. Medical Device: Definition, History and Economic Background -- 1.1. Definition -- 1.2. Examples of medical devices -- 1.2.1. Surgery equipment -- 1.2.2. Medical imaging -- 1.3. Medical device industry -- 1.3.1. The industrial sector -- 1.3.2. Importance of medical device in the economy -- Chapter 2. Medical Device Design and Development -- 2.1. Medical device design is much more than device design -- 2.2. Product ideation and conceptualization -- 2.3. Regional and international standard for addressing regulation and compliance need -- 2.4. EU medical device regulation (MDR2017) -- 2.5. Design control regulations (for FDA 21CFR820) -- 2.6. Risk management procedures (ISO 14711) -- 2.7. Conclusion -- Chapter 3. Medical Sensors -- 3.1. Selection of medical sensors -- 3.1.1. Introduction -- 3.1.2. Electric signalization -- 3.1.3. Thermal measurement -- 3.1.4. Biomechanical measurements -- 3.1.5. Exercises -- Chapter 4. Measurement Quality -- 4.1. Measurement quality -- 4.1.1. Introduction -- 4.1.2. Calibration -- 4.1.3. Vocabulary -- 4.1.4. Metrological testing -- 4.1.5. Evaluating uncertainties -- 4.2. Key notions in signal processing -- 4.2.1. Signal sampling -- 4.2.2. Denoising a signal -- 4.2.3. Time frequency representation -- 4.2.4. Extracting the information for high quantity of noisy data -- 4.2.5. Exercises -- Chapter 5. Numerical Simulation and Medical Devices -- 5.1. Role of numerical simulation in medical device design -- 5.1.1. General design workflow for medical device -- 5.1.2. Introduction example -- 5.2. General context -- 5.2.1. Agency policies -- 5.2.2. Report structure -- 5.3. Report details -- 5.3.1. Background -- 5.3.2. Question of interest -- 5.3.3. Computation model -- 5.3.4. Model risk -- 5.3.5. Model validation -- 5.3.6. Ranking the model credibility.

5.3.7. Computational model credibility assessment -- 5.3.8. Results and discussion -- Chapter 6. Global Ethics Rule Beyond Clinical Trials -- 6.1. Medical ethics, from Hippocrates to the Declaration of Geneva -- 6.2. Evolution of ethics rules for clinical trials -- 6.3. Declaration of Helsinki -- 6.4. Ethics for engineers -- Chapter 7. Clinical Trials Process -- 7.1. Clinical trials in the design process -- 7.1.1. Before clinical testing -- 7.1.2. Institutional guidelines -- 7.1.3. Clinical trials before going to market (EU -- MEDDEV 2.7/1) -- 7.1.4. Bibliographically-based clinical proof and demonstration of equivalence -- 7.1.5. Clinical trials after going to market (EU -- MDR2017 and EU -- MEDDEV 2.12-1 rev 8) -- 7.2. Insight: MDR2017 and the French implementation -- 7.3. Classification of clinical trials -- 7.4. Insight: the ISO 14155 -- 7.4.1. Ethics consideration -- 7.4.2. Planning of the clinical investigation -- 7.4.3. Clinical investigation follow-up -- 7.4.4. Ending a clinical investigation -- Chapter 8. Introduction to Biostatistics -- 8.1. Introduction -- 8.2. Selection rules for statistical processing -- 8.3. Hypothesis testing -- 8.3.1. General principle on hypothesis testing -- 8.3.2. Error of the first and second king, power of a test -- 8.3.3. Comparing two sets of variables: parametric or nonparametric testing -- 8.3.4. Example: pressure applied by a compression bandage -- 8.4. Linear regression -- 8.4.1. Mathematics of linear regression -- 8.4.2. Analysis of variance -- 8.4.3. Correlation between parameters -- Chapter 9. Longitudinal Practice with Sensor Design -- 9.1. Design -- 9.2. Session 2: building an IMU-based sensor -- 9.2.1. Step 1: software installation -- 9.2.2. Step 2: wiring -- 9.2.3. Step 3: uploading code to the board -- 9.3. Session 3: signal procession and metrology -- 9.4. Session 4: sleep apnea.

Chapter 10. Longitudinal Practice Focused on Clinical Trial -- 10.1. Session 1: frailty problems -- 10.2. Session 2: project draft -- 10.3. Session 3: design of a clinical trial (1) -- 10.4. Session 4: design of a clinical trial (2) -- 10.5. Session 5: defense in front of the IRB -- Appendix: Clinical Trial Form -- References -- Index -- Other titles from ISTE in Health Engineering and Society -- EULA.