ISO 14971:2019 – The Scope of the Standard
Description:
Risk management for medical devices is an absolute requirement worldwide. The review of the Risk Management File is getting a critical and thorough assessment by regulatory bodies. Beyond that, good Risk Management just makes good business sense. Nobody wants their device to harm patients and there can be severe financial repercussions if devices do cause harm. ISO 14971:2019 is the latest version of the most generally accepted standard for medical device risk management. This program is tailored around that standard. In this course we will focus on the scope of the standard.
Curriculum for this course:
Program Introduction
| Overview | 1 min 01 secs |
| Learning Objectives | 1 min 31 secs |
| Who Will Benefit from This Training? | 1 min 21 secs |
| Materials Used | 1 min 10 secs |
| Program Overview | 1 mins 11 secs |
| Course Introduction | 1 min 09 secs |
| Course Overview | 1 mins 10 secs |
| Learning Objectives | 1 mins 22 secs |
Section 1: Scope
| Always Managing Risk | 1 min 05 sec |
| An Holistic Approach | 1 min 10 secs |
Section 2: Normative References
| Normative References | 1 min 12 secs |
Section 3: Terms and Definitions
| Benefit | 1 min 01 secs |
| Harm & Hazard | 1 min 13 secs |
| Hazardous Situation | 1 min 33 secs |
| Reasonably Foreseeable Misuse | 1 min 06 secs |
| Residual Risk, Risk and Risk Control | 1 min 19 secs |
| State of the Art | 1 min 07 secs |
| Use Error | 1 min 04 secs |
| Revisiting Section 1: Scope | 1 min 03 secs |
| Is / Is Not | 1 min 25 secs |
| Where it Fits | 1 min 28 secs |
| Expectations from 60601 | 1 min 32 secs |
| Integration with Usability Engineering | 1 min 08 secs |
| Integration with Software Development | 1 min 01 secs |
Section 4: General Requirements for Risk Management Systems
| Section 4.1 Risk Management Process – Part 1 | 1 min 10 secs |
| Section 4.1 Risk Management Process – Part 2 | 1 min 01 secs |
| Section 4.2 Management Responsibility – Part 1 | 1 min 25 secs |
| Section 4.2 Management Responsibility – Part 2 | 1 min 09 secs |
| Section 4.3 Competence of Personnel – Part 1 | 1 min 45 secs |
| Section 4.3 Competence of Personnel – Part 1 | 1 min 33 secs |
Conclusion
Final Assessment
Certification
Revision History
| Course updated to fix assessment functionality and course functionality. | V2.0 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-333 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V2.0 -
Effective Date: 27/09/2021
Reviews:
This is a wonderful introduction to the world of risk management for medical devices, explained in a clear concise manner this is a must do training for anyone who needs to understand risk.
Another great training resource for our training department, looking forward to the release of the rest of the courses in this program.
Related courses:
21 CFR Part 820 Subpart A – General Provisions
21 CFR Part 820 Subpart B – Quality System Requirements
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
ISO 13485:2016 Product Realization (Chapter 7 – Part A)
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Data Integrity Awareness: CSV Best Practices
21 CFR Part 11 – Electronic Records
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