Regulatory / Health specific

Launching a project in the very regulated health sector, means you need a very clear view on the legal framework. Our experts can support you with all of these questions, which can sometimes be very sensitive.

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Make your company (better) known from the Belgian Federal Agency for Medicines and Health Products (FAMHP).

You are developing or commercializing a e-health/medical device solution? You would like to be better informed of new initiatives, regulatory...

Developers of medical softwares, medical mobile applications,… are you well aware of the impact of the European Medical Devices Regulation on your business ?

Until recently some medical software, mobile applications and other new technologies applied to healthcare were not considered as medical devices....
 What are ISO norms? Is ISO applicable to medical devices?

What are ISO norms? Is ISO applicable to medical devices?

There are plenty of ISO norms (International Organization for Standardization) who, depending on the industry and activities, aim to define...
 What needs to be validated in my product before I can commercialize it?

What needs to be validated in my product before I can commercialize it?

Launching a product that touches the health sector means that you need to be compliant with a series of national...
 Does my product need to be traceable? What are my obligations?

Does my product need to be traceable? What are my obligations?

Medical devices are not standard products: they need to respect a set of norms before they can be commercialized. This...
 How to build a good prototype quickly

How to build a good prototype quickly

The development of innovation products in the health sector often pass through a prototyping phase which allows to validate the...
 What is GDPR, and how to be compliant?

What is GDPR, and how to be compliant?

GDPR – or General Data Protection Regulation – is in force on the European Territory since May 25th 2018. This...
 Is my solution a Medical Device? Or E-health?

Is my solution a Medical Device? Or E-health?

Whenever you develop a product in the Health sector, it is important to determine whether it falls in the category...
 What is CE marking? Does my product need it?

What is CE marking? Does my product need it?

CE marking, in force since 1993, ensures that consumers use products that are conform to European Legislation. It also means...
 Regulatory / Health Specifics

Regulatory / Health Specifics

Launching a project in het health sector is a special entrepreneurial adventure, as the health sector has so many unique...