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Risk Management

Risk Management Plans For Your Medical Device

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.

At Europlaz, we cover all aspects of the development of a medical device from concept to the manufacture and rollout  of the product.

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.


medical device risk management
medical device risk management

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.

About Europlaz

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.

For further information you can watch our Corporate Video to the left-hand side, view our Corporate Brochure or Contact Us.

Book a Meeting

To learn more about Europlaz’s services and the different medical devices we have helped develop, book a telephone meeting with one of the team.

To do this simply use the Schedule Meeting button below.

Alternatively you can contact us by telephone or email.

01621 773471

All Other Services

Medical Device 3PL

Assisting with the entire logistic process from manufacturing, storage, picking to shipping.

Renting R&D Space

For clients who are undertaking advanced stage R&D work and require our facilities and services.


Understand our Ethylene Oxide, Gamma and Auto Clave sterilisation process.

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