A Methodology for Ultrasound Product Development - Ultrasonic ...

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Ultrasound Medical Device Challenges Regulatory Fundamental • Bioeffects • Efficacy • Safety • Design Control • Process Control Bureaucratic • Documentation • Design Control • Process Control • PMA or 510k backup 14
Development Project Outline Goal: Risk Reduction! • Lay out the ground work • Develop device and evaluate • File patents • Set up manufacturing • … wait for business success! 15
Page 1 and 2: A Methodology for Ultrasound Produc
Page 3 and 4: Ultrasound Medical Devices - the Ch
Page 11 and 12: Ultrasound Medical Device Challenge
Page 13: Ultrasound Medical Device Challenge
Page 17 and 18: Development Project - Ground Work T
Page 19 and 20: Development Project Project outline
Page 21 and 22: Case Study: HIFU for Fat Ablation
Page 23 and 24: Case Study: HIFU Location Problems
Page 25 and 26: Case Study: HIFU Uniformity Problem
Page 27 and 28: Case Study: HIFU Surface Cooling 27
Page 29 and 30: Case Study: HIFU Gel Burns 29
Page 41 and 42: Case Study: HF transducer for imagi
Page 43 and 44: Case Study: High Frequency Imaging
Page 45 and 46: Case Study: High Frequency Imaging
Page 47 and 48: Case Study: Ranging Catheter Applic
Page 49 and 50: Case Study: Ranging Catheter Applic
Page 51 and 52: Case Study: Ranging Catheter Conclu
Page 53 and 54: What we’ve learned - 1 • Ultras
Page 55 and 56: What we’ve learned - 2 • A good
Page 57 and 58: What we’ve learned - 3 Medical de

A Methodology for Ultrasound Product Development - Ultrasonic ...

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