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.

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