Covartim products

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

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

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

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.

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