What are you working on?

Over the years our specialists have developed specific expertise in each category of product.
Here below you can learn what we do for each category and how pleased are our clients with what we have done for them.

Software

A standalone software, such as a mobile or web application, can fall within the definition of a (IVD) medical device. Therefore, the placing on the market is well regulated and specific actions need to be undertaken.

We analyse your product and determine if it qualifies as a (IVD) medical device. If so, we will conclude on its classification and the regulatory pathway.
We manage the transition of a self-certified product under MDD to MDR.
We assess impact of changes.
We guide through the compliance to ISO 62304.

Implant

An (active) implant being resorbable or not, custom made or not, is a high risk device that will require quite a big amount of data to show safety and performance.

We produce a development plan that will indicate the necessary steps towards the market, including development, verification and validation activities planning and costs.
We manage product development and the certification process.
We take care of transition from MDD to MDR.

Equipment

An equipment is an active device that requires specific validation with regards to its safety.

We manage product development and the certification process.
We take care of transition from MDD to MDR.
We guide through the compliance to ISO 60601.

Instrument

An instrument, being disposable or not, may be surgically invasive or not or may be an accessory to another medical device.

We produce a development plan that will indicate the necessary steps towards the market, including development, verification and validation activities planning and costs.
We manage product development and the certification process.
We take care of transition from MDD to MDR.

IVD

An IVD and its reagents and associated specimen receptacles follow another development and certification route than the medical devices.

We produce a development plan that will indicate the necessary steps towards the market, including development, verification and validation activities planning and costs.
We manage product development and the certification process.
We take care of transition from IVDD to IVDR.

Combination products

A medical device containing a medicinal product needs to be developed and validated considering the dual regulatory framework of devices and drug.

We produce a development plan that will indicate the necessary steps towards the market, including development, verification and validation activities planning and costs.
We manage product development and the certification process.
We take care of transition from MDD to MDR.