CPDEquivalent to 14 hours
CERTIFICATESAll delegates will receive a certificate on completion.
Risk Analysis and FMEA for Medical Devices based on the requirements of ISO 14971.
On the first day of this 2-day interactive and practical course you will learn about the requirements of ISO 14971 and how to carry out risk analysis from start to finish. The second day will explore in greater depth the role of FMEA and how to apply it in your risk management process.
As well as workshops and discussions around topics such as hazard Identification and risk control and reduction, delegates will have the opportunity to talk as a group about the stages of FMEA.
- 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 would like to understand risk analysis and control in bringing medical devices to market without further detail around FMEA, you may like to look at our 1-day ISO 14971 Risk Analysis 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 application of risk analysis methodologies such as FMEA 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 they might occur
- apply risk analysis methodologies to medical devices
- apply risk evaluation and risk control principles to their devices – including regulatory requirements, technical costs, accident costs, liability costs and insurance costs – all of which feed into decision-making around acceptability of risks when bringing a device to market
This 2-day course delivers all the content of the ISO 14971 Risk Analysis for Medical Devices, and on the 2nd day offers greater detail about Failure Mode and Effects Analysis (FMEA).
FMEA is a Core Tool for anticipating and preventing defects in design and manufacture. If you are interested in Core Tools, including FMEA, you may like to look at our programme of Core Tools training.
Risk analysis for medical devices is required by the FDA for the US market and as part of the European Union’s directive for EU markets. By carrying out risk analysis, medical device developers and manufacturers can identify and assess the likelihood and impact of hazards on safety.
Failure Mode and Effects Analysis is a technique for exploring where and how failure can occur in the development and manufacture of a product, enabling organisations to better control or eliminate those failures.
FMEA can be applied in the design and manufacturing of many products. This Risk Analysis and FMEA for Medical Devices training course focuses on the how designers and manufacturers of medical devices can reduce failures.
We have enjoyed the company of delegates from many organisations within the medical manufacturing industry, including those involved in products such as ventilators and wound protection.
As one delegate reported: ‘It was very useful to learn about the gold standard from many different industries and where we sit with regards to other companies within medical devices, and to learn of all the ways that we can improve.’
NWROCU|4th Dec, 2023
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