This one-day intensive course helps medical device manufacturers understand the benefits and impact of ISO 14971:2019. It’s ideal for anyone in a quality assurance, regulatory, engineering or manufacturing role. We also recommend a basic knowledge of medical device development, quality assurance and ISO 13485:2016.
Through a mix of practical activities, classroom learning and group discussion, you will learn risk management terminology and the stages of the risk management process. You’ll also be able to identify links between ISO 149721:2019, ISO 13485:2016, MDR 2017/745 and IVDR 2017/746.
Prerequisites
You should have experience with, or basic knowledge of, quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development, quality assurance and ISO 13485:2016.
Pedagogical objectives
- Understand, interpret and explain key requirements of ISO 14971:2019
- In-depth knowledge of how ISO 14971:2019 links to ISO 13485 and the regulations; MDR 2017/745 and IVDR 2017/746
- Carry out risk management for medical devices within your organization
- Gain an internationally recognized BSI training certificate from your partner in learning
Skills to be acquired
Upon completion of this training, you will be able to:
- Define risk management terminology
- Explain how risk management relates to the product lifecycle
- Outline the stages of the risk management process
- Define the key deliverables of the risk management process
- Apply risk management principles within your organization
- Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745 and IVDR 2017/746Targeted
Targeted audience
This course is ideal for you if you’re in a QA/Regulatory/Engineering/Manufacturing role involved in medical device design, development and manufacturing.
Pedagogical, technical and framing means
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
