Personalized medical devices adapted to end users and developed according to current regulatory requirements
3DEUS Dynamics developed an innovant and unique process of manufacturing called « Dynamic Molding ». This innovation combines the advantages of 3D printing and injection molding, thus allowing new possibilities of production and materials.
Silicone Anatomical models made by Dynamic Molding are particularly appreciated in the Healthcare sector to reproduce very faithfully the flexibility of soft tissues and the complex geometry of organs.
The use of anatomical models defines their regulatory status
According to European regulation, the specific patient anatomical models used to prepare a surgery are considered as surgical aids and therefore classified in the class 1 medical device (MD) category. As such, they require a regulatory process and quality controls throughout of the value chain thus ensuring the surgeon a reproduction as close as possible to the anatomy of the patient.
They are produced from the 3D imagery provided by the healthcare professional (Scanner, MRI or Ultrasound) corresponding to the patient who will then be treated.
According to European regulation, anatomical models used for training or non-patient specific training are not considered as medical devices. These models are not intended directly for patient care.