Risk Analysis and FMEA for Medical Devices
DURATION
2 daysCPD
Equivalent to 14 hoursCERTIFICATES
All delegates will receive a certificate on completion.DELIVERY OPTIONS
Understand the steps involved in the risk management process of bringing medical devices to market, and the value of Failure Mode and Effects Analysis (FMEA), on this Risk Analysis and FMEA for Medical Devices training course.
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
Delegates who complete all elements of the course will receive a certificate in recognition of their new understanding of risk analysis and FMEA for medical devices.
In-company training availability
Receive this course exclusively for your organisation, either in-person at your chosen venue or online in our user-friendly Virtual Classroom.
Enjoy cost-effective flexibility and personalised learning with tailored messaging designed to address your unique business challenges.
In-Person | |
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Delegate numbers | Up to 12 |
Total fees | £3995 + VAT |
Virtual Classroom | |
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Delegate numbers | Up to 10 |
Total fees | £3695 + VAT |
What's included
- Delegate certificates of attendance.
- Comprehensive course materials and handouts.
- All tutor expenses and courier fees.
- Free cancellation up to 13 working days before commencement.
For courses held outside the UK or requiring significant adjustments, we will clearly inform you of any additional fees before you book.
Next steps
Find out our availability and enquire about this course by completing the form and our training team will get in touch with you.
Alternatively contact us on 0333 123 9001 or email contact@bywater.co.uk to discuss your requirements.
Enquire
Complete the following form to enquire about this course and our training team will be in touch.
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.’
Customer reviews
BM Trada|24th Jul, 2024
Trulife Ltd|4th Jul, 2024
Volac International Ltd|2nd Jul, 2024
British American Tobacco (BAT)|1st Jul, 2024
Europlaz Technologies Ltd|28th Jun, 2024
British American Tobacco (BAT)|25th Jun, 2024
Supply Servis S.R.O.|19th Jun, 2024
Forensic Analytics Ltd|17th Jun, 2024
Primer Design Ltd|12th Jun, 2024
TUV SUD Ltd|11th Jun, 2024
Salisbury NHS Foundation Trust|11th Jun, 2024
Am Healthcare Group|7th Jun, 2024