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Protect your company by understanding and following the relevant regulations for your industry. We can help you select and navigate the necessary regulations, define the necessary procedures, and create a practical framework.

We assist Manufacturers – Distributors – Importers from the following sectors:

Medical device sector

Medical Devices

Products or equipment intended for a medical purpose. These can range from simple tongue depressors to complex artificial organs, or even products like medical journal software.

Welfare technology sector

Health and Welfare Technology

A sub-category of medical devices designed to improve the life and quality-of-care for patients – often by increasing security, activity, participation or independence.

Municipalities and hospital sector

Local Councils and Hospitals

Did you know that you become a 'medical device manufacturer' if you alter, adapt or use medical devices in a way other than intended?

See more details in the box below.

RAQA - Did you know? icon

Did you know?

Changing and altering devices can be dangerous
If you alter a medical device with a custom attachment or alternative part than specified, you are then defined as a medical device manufacturer. The change can be as simple as using a different mattress on a hospital bed or adding a headrest to a wheelchair, but can have important consequences with regards to responsibility and even more daunting, liability.

We can answer your questions and help you navigate the system, finding the best solution for your organisation and your clients.

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