ABSTRACT

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv

chapter |6 pages

Introduction

chapter 2|84 pages

Safety and Effectiveness

chapter 3|68 pages

Technical Documentation

chapter 4|78 pages

Pre-Market Phase

chapter 6|120 pages

Post-Market Phase