หลักสูตร RISK MANAGEMENT ISO 14971:2019 Medical devices — Application of risk management to medical devices

THE IMPORTANCE OF RISK AND MEDICAL DEVICES

         I remember the first day on the job as a medical device product development engineer. During the orientation, I was shown a company video that included employees throughout the organization. Every person shown on the video talked about a common theme: realizing that the medical devices they were part of bringing to market could someday be used on a friend, family member, and possibly themselves. It started to hit me. The gravity and importance of the job I was about to start. Medical devices that I designed and developed could be used on my mom, sister, kids, and so on. Imagine this from the perspective of a patient going in for any medical procedure. The patient probably thinks very little about the risks of the medical devices about to be used. Generally, the patient trusts the expertise of the clinicians. The patient seldom wonders if the products used by the clinicians are safe and have been thoroughly and rigorously tested. The patient, often unknowingly, accepts the risks of the medical device you and I design, develop, and manufacture. And this is exactly why Risk Management is so important to the medical device industry. You must know that the medical devices you are involved with bringing to patients and end-users are safe.

• Section 1: Introduction

• Section 2: Terms and Definitions

• Section 3: Key Changes in ISO 14971

• Section 4: General requirements for risk management system

• Section 5: Risk analysis

• Section 6: Risk evaluation

• Section 7: Risk control

• Section 8: Overall residual risk evaluation

• Section 9: Risk management review

• Section10: Post-production activities

• Annex

• Summarize

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