CPDEquivalent to 7 hours
CERTIFICATESAll delegates will receive a certificate on completion.
Risk Analysis for Medical Devices based on the requirements of ISO 14971.
On this practical 1-day course you will examine all steps of the risk management process, from risk analysis and risk evaluation through risk control to post-production information gathering.
The course employs interactive workshops to allow you to practise what you are learning, as well as group discussions on topics such as risk control, hazard Identification and techniques for risk analysis.
- R&D managers/engineers
- RA/QA managers/engineers
- management representatives
- members of multi-discipline design teams
- members of design review teams
- sales and marketing management
- product, project, and programme managers
- internal auditors
If you wish to explore more deeply into Failure Mode and Effects Analysis (FMEA) at the same time as learning about risk analysis, we recommend you look at our 2-day Risk Analysis and FMEA for Medical Devices training course.
- expectations of the FDA and the EU in applying risk analysis to medical devices
- risk management requirements and the purpose of ISO 14971
- the application of ISO 14971 to medical devices
- the principles of risk management planning in developing procedures and practices to analyse, evaluate and control risks
- sources of information and further development
- apply the process to conduct risk analysis to identify hazards, their severity and the probability that they might occur
- apply risk evaluation and risk control principles to their devices, including regulatory requirements, technical costs, accident costs, liability costs and insurance costs, which affect decision-making on the acceptability of risks in bringing a device to market
If you are interested in practical skills for reducing risk of failure in medical device development and production, you may like to take a look at our Risk Analysis and FMEA for Medical Devices training course.
As well as looking at the steps of the risk management process, this risk analysis and FMEA course takes a deeper look at Failure Mode and Effects analysis for medical devices. FMEA techniques are used to identify and reduce the risk of product failure.
We offer a range of risk management courses looking at the requirements of ISO 31000:2018, explaining the role and implementation of risk management within an organisation.
Our ISO 14971 risk analysis for medical devices training is available on a dedicated basis for your organisation, allowing you to choose a convenient time and location – face-to-face or online in our Virtual Classroom. Please contact our training team to discuss your requirements.
Metropolitan Police Service|16th Nov, 2023
Sense Biodetection Ltd|13th Nov, 2023
Premier Partnership|10th Nov, 2023
Sense Biodetection Ltd|8th Nov, 2023
Animal and Plant Health Agency (APHA)|7th Nov, 2023
Animal and Plant Health Agency (APHA)|27th Oct, 2023
Orthoplastics Ltd|27th Oct, 2023
The Royal Mint|25th Oct, 2023
Private|24th Oct, 2023
DSTL|17th Oct, 2023
Swann-Morton Ltd|13th Oct, 2023
Mars|10th Oct, 2023