All medical devices need to minimise the risk of harm to the patient, user or intermediate handler and the risks of using a medical device need to be outweighed by the benefits it will bring. This step is crucial to the development of all medical products as it ensures patients can trust the process; of testing and treatment with confidence.
To support your project, Europlaz generates risk management plans for all medical device projects, to ensure that all risks within a project are identified, managed and suitably mitigated.
Failure Mode and Effect Techniques Analysis (FMEA)
Specific processes are analysed using Failure Mode and Effect techniques Analysis (FMEA) which systematically reviews the process and provides a feedback loop which is used to identify, reduce and control risks. This system, in use since the 1940s, is the backbone of our medical device risk management service and focuses on two key areas;
Failure Modes: Studies into the ways in which something might fail. This includes all errors and defects in the production process.
Effects Analysis: This phase is a continuation of Failure Modes whereby specialist teams study the potential consequences of failures.
This information is then categorised by its severity, frequency and detection methods to ensure the continued improvement of production and use.
FMEA Medical device risk management is best undertaken with a full understanding of the device and the processes used to manufacture the device.
To achieve this Europlaz converse with your medical device risk management team to provide specialist technical knowledge on the activities we undertake and to gain your insight into your product when carrying out our internal risk management for your product. This provides a fresh perspective and can be the difference in critical medical situations.
Since 1970 we have built a reputation for innovation, quality, and cost-effectiveness.
We use our experience and state-of-the-art technology to streamline all stages of the medical device manufacturing process for you – moving your product quickly and safely through development, and speeding up regulatory approval of medical devices.
Our UK-based ISO 13485 certified and FDA-compliant facility means that we have complete control of the process, from under one roof. We are flexible, and resourceful, and can take on projects of any size. Our clients range from small start-ups to international blue chip medical device suppliers.
Learn more about what we do by watching our corporate video.
Why not book in a telephone meeting with us to learn more about our service offerings? Use the meeting scheduler below and select a convenient date and time.
Alternatively you can contact us by telephone or email.
ISO certification and FDA registration are important watchwords when it comes to the manufacture of medical devices. But why? What...
To begin discussions about a specific project please complete the form below and we will be back in contact. Alternatively, you can book a telephone call with us using our online Meeting Scheduler. If you are interested in one of our vacancies, please apply through the Careers Page.