Master Medical Device Development & Risk Management Course

Become a Medical device development and risk management expert inline with ISO 14971:2019

What you'll learn

By completing this course you will gain a comprehensive knowledge of medical device development and risk management per ISO 14971:2019

Understand when and how to apply risk management through a the medical device lifecycle.

Understand how to plan a medical device development.

Gain a deep understanding of medical device design controls and systems engineering principles.

Understand how ISO 14971 relates to other important international standards including IEC 60601, IEC 62304 and ISO 13485.

Have a clear understand how to easily document design control and risk management activities.

Requirements

While prior experience in medical devices or risk management is beneficial, the course is structured to provide foundational knowledge and advanced insights. Both beginners and experienced professionals will benefit from the material.

Description

This comprehensive course provides an in-depth education on the application of risk management per ISO 14971:2019 during the design and development of medical devices.You will learn to avoid the major mistakes people make that stifle new medical device product developments. Access countless practical examples providing you with the knowledge to easily develop safe and effective medical devices in the fastest possible time. Peek behind the curtain at our medical device templates documentation pack designed to make your regulatory submissions a walk in the park.This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.The course is fully aligned with ISO 14971:2019, the international standard for the application of risk management to medical devices. You will learn how to apply each phase of the risk management process outlined in the standard to medical device design and development.It is recommended to complete the course over 5 days, taking about 4 hours a day to complete, and upon successful completion, participants will be proficient in medical device development & the application of medical device risk management over the entire medical-device lifecycle.Start your journey today to become a medical device development & risk management expert.

Overview

Section 1: Why is Risk Management Important ?

Lecture 1 What you will learn ?

Lecture 2 Course Introduction

Lecture 3 What is RISK ?

Lecture 4 Medical Devices and Risk

Lecture 5 What is a MEDICAL DEVICE?

Lecture 6 What is RISK MANAGEMENT?

Lecture 7 MEDICAL DEVICE Failures

Lecture 8 MEDICAL DEVICE BENEFITS

Lecture 9 ISO 14971 and the CFR/MDR

Section 2: Medical Device Development

Lecture 10 Chapter 2 Course Notes

Lecture 11 The LIFECYCLE

Lecture 12 Design & Development Overview

Lecture 13 ISO 14971 and ISO 13485

Lecture 14 Phase Strategy

Lecture 15 Planning

Lecture 16 Documentation and RECORD-Keeping

Lecture 17 INTENDED USE

Lecture 18 USER NEEDS & VALIDATION

Lecture 19 REQUIREMENTS and Architecture

Lecture 20 SYSTEM Architecture

Lecture 21 Phase Strategy for a Complex Product

Lecture 22 Design PROCESS and DESIGN OUTPUTS

Lecture 23 VERIFICATION

Lecture 24 Is our Digital Thermometer Safe?

Lecture 25 Design Traceability

Lecture 26 Document Templates

Lecture 27 Product Development Plan Template

Lecture 28 User Needs Specification Template

Lecture 29 Product Requirements Document Template

Lecture 30 Product Detailed Design Specification Template

Lecture 31 Design Verification Test Protocol Template

Lecture 32 Design Verification Test Report Template

Lecture 33 Design Review Template

Lecture 34 Common Questions

Section 3: Risk Management per ISO 14971

Lecture 35 Download Chapter 3 Notes

Lecture 36 RISK ASSESSMENT

Lecture 37 RISK ANALYSIS

Lecture 38 REASONABLY FORESEEABLE MISUSE

Lecture 39 Characteristics Related to Safety

Lecture 40 HAZARDS

Lecture 41 Quantitative Probability Estimation

Lecture 42 Qualitative Probability Estimation

Lecture 43 SEVERITY of HARM

Lecture 44 Advice from the Trenches

Lecture 45 Evaluating RISK

Lecture 46 RISK CONTROL

Lecture 47 Verify RISK CONTROL

Lecture 48 RESIDUAL RISK

Lecture 49 RISKS arising from RISK CONTROL measures

Lecture 50 Completing RISK MANAGEMENT

Lecture 51 Documentation Templates

Lecture 52 A List of Common HAZARDS

Lecture 53 Other International Standards

Lecture 54 FMEA and ISO14971 (Part 1)

Lecture 55 FMEA and ISO14971 (Part 2)

Section 4: Production and Post-Production

Lecture 56 Download Chapter 4 Notes

Lecture 57 LIFECYCLE (Recap)

Lecture 58 RISK CONTROLS in Production & Post-Production

Lecture 59 PFMEA

Lecture 60 Information

Lecture 61 Information Review

Lecture 62 Actions

Lecture 63 Implementing Reviews and Actions

Lecture 64 Data Collection

Lecture 65 BUG-Tracking Procedure

Lecture 66 Change Control Procedure

Lecture 67 RISK MANAGEMENT In POST-PRODUCTION Example

This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.